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  • Senior Director, Global Deployment & Logistics (Remote)

    3Ds 3.8company rating

    Remote job

    Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week in accordance with Company policy. About our Company: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. Discover more at **************** . About the Team: The Director, Global Deployment & Logistics will lead and drive the strategy for the logistical execution and operational support of our clinical trial solutions globally. This pivotal role ensures the seamless procurement, provisioning, deployment, and support of hardware (devices, wearables, sensors, etc.) required for clinical trials utilizing our software (e.g., eCOA, eConsent). Additionally this role will provide strategic and operational leadership for the management, security, and lifecycle of all provisioned devices utilized by patients and sites in global clinical research trials. This position requires a strong blend of supply chain and mobile device management expertise, vendor oversight, financial acumen, and experience in a regulated clinical or pharmaceutical environment.) Responsibilities: 1. Strategic Logistics & Supply Chain Management Develop, implement, and maintain the global logistics and supply chain strategy for hardware used in clinical trials, ensuring alignment with project timelines and company financial goals. Oversee the entire device lifecycle, including procurement, inventory management, provisioning, global distribution, returns, and destruction. Design and execute supply plans that align with clinical trial timelines and requirements. Drive innovation and process improvements using technology and analytics to optimize forecasting, inventory levels, and responsiveness to trial demands. 2. MDM Strategy and Operations Lead the vision, strategy, and execution of the Mobile Device Management (MDM) program across all Patient Experience solutions. Oversee MDM policies and procedures for security, configuration, remote wipe, app distribution, and device tracking in compliance with GxP and data privacy regulations (e.g., GDPR, HIPAA). Work closely with the Product team to help coordinate device requirements (tablets, phones, wearables, sensors, data plans, etc.) for product release cycles. 3. Vendor and Stakeholder Oversight Manage relationships with external vendors, suppliers, couriers, and customs brokers involved in device provisioning, shipping, and help desk support. Negotiate contracts, monitor key performance indicators (KPIs), and manage vendor performance to ensure quality, reliability, cost-effectiveness, and geographic coverage. Collaborate cross-functionally with Clinical Operations, Project Management, Product, Finance, and Sales teams to ensure smooth order fulfillment, resource alignment, and budget adherence. Act as the primary escalation point for all deployment and provisioning issues, troubleshooting complex problems to minimize trial disruption. 4. Operational Excellence and Compliance Ensure that all logistics and device management activities are in strict compliance with international trade regulations, GxP (GCP, GDP, GMP), ICH guidelines, and regulatory requirements for clinical supplies. Develop and update Standard Operating Procedures (SOPs), Work Instructions (WIs), and training materials to scale activities for implementation and enablement engagements. Identify opportunities for cost reduction and increased profit margins. Qualifications: Minimum of 8+ years of experience in supply chain management, clinical logistics, or clinical supply services and mobile device management, with at least 4-6 years in a managerial or supervisory capacity. Minimum of 5+ years of experience managing vendors. Bachelor's degree in Supply Chain Management, Business Administration, Engineering, or a related field; advanced degree or relevant certification (e.g., APICS, CPIM, CSCP) preferred. Expert knowledge of logistics and mobile device management within the clinical trial, biotech, or medical device industry, Proven advanced expertise with order processing systems, inventory management software and MDM solutions. Demonstrated knowledge of import/export documentation and global trade compliance requirements. Exceptional leadership, team development, and cross-functional collaboration skills. Strong analytical skills with the ability to interpret data, track KPIs, and drive continuous improvement. Excellent written and verbal communication, with a proven ability to interact with senior leadership, sales teams and external clients. Demonstrated ability to manage multiple complex projects simultaneously in a fast-paced, high-stakes environment. As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. The salary range for positions that will be physically based in the NYC Metro Area is $184,500.00 to 248,00.00 The salary range for positions that will be physically based in the California Bay Area is $194,250.00 to 216,000.00 The salary range for positions that will be physically based in the Boston Metro Area is $181,500.00 to 242,000.00 The salary range for positions that will be physically based in Texas or Ohio is $162,000.00 to 216,000.00 The salary range for positions that will be physically based in all other locations within the United States is $165,000.00 to 220,000.00 Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; flexible paid time off; and 10 paid holidays per year. Equal Employment Opportunity: In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applications will be accepted on an ongoing basis until the position is filled. #LI-TC1 #LI-Remote Inclusion statement In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state laws and local ordinances. We are committed to fair employment practices and will evaluate all candidates based on their qualifications, regardless of past arrest or conviction history. Salary Pay Transparency Compensation for the role will be commensurate with experience. The total expected compensation range will be between $165000 and $220000, representing the base salary (or annualized salary based on estimated hourly compensation) and target bonus.
    $194.3k-216k yearly 3d ago
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  • Care Coordinator I

    Integrated Resources 4.5company rating

    Columbus, OH

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Care Coordinator I Duration: 5+ Months (possible extension) Location: Columbus, OH Responsibilities : · Monday to Friday 8am to 5pm Working in Office- but need to be mobile as they will be making visit for home assessments While in office: Reviewing Assessment with medical directors to determine if patients are receiving the level of in home care and if they need referrals as well Working with children with special needs. · No clinical care Top Three Skill Sets: Experience with home health visit or case management, working with children and computer skills. · Working with home health agencies and/or Medicaid Interview. Face to Face Summary: · Responsible for the assessment and review, coordination and distribution of review decisions for members identified with medical, surgical, and long-term care, needs including home and community-based waiver recipients. · Interacts with Medical Directors, HCS department staff, various other staff and providers and practitioners to ensure timely receipt of decisions in accordance with Client policies, procedures and processes. Adheres to the company/department's confidentiality and HIPAA compliance programs. · Adheres to the company/department's fraud and abuse prevention/detection policies and programs. Essential Functions:- · Provides various care coordination activities in collaboration with the client's managed care organization (MCO), health care providers, other HCS staff, involved medical case managers/care coordinators, public agencies, and other providers as required. Documents all findings, contacts and interventions. · Maintains case-specific communication with state agencies, healthcare individuals and support systems to promote efficient and well-coordinated quality care. · Provides scheduled assessment and review of health needs, individualized care plans, and monitoring of Medicaid eligibility. · Confers with appropriate staff, including, but not limited to, case managers/care coordinators, medical directors, social workers, health care providers and practitioners, and state agency staff to provide timely and accurate service authorizations and reviews based on a recipient's current needs/functioning. · Communicates review decisions and prior authorizations to various professionals involved in the client's care, including practitioners and primary care providers (PCP). · Shared responsibilities for professional responses to client, provider and practitioner, and state agencies via telephone. · Assists other department team clients when needs are identified. · Establishes and maintains professional rapport with providers, clients, public agencies, and others involved in the client's care. Knowledge/Skills/Abilities: · Must have strong oral and written communications skill to ensure accurate exchange of information and to build rapport that will ensure the trust, confidence and cooperation of others in a work situation. · Must have the skills to learn and adapt to company policies and procedures as they relate to hospital authorization/denials, physician review, appeals, etc. · Must have the ability to successfully apply established guidelines and regulation to individual and specific situations. · Must have excellent organization skills to establish and maintain a variety of records necessary to provide complete and accurate information and documentation for relevant and appropriate medical determination. · Ability to perform independently and to handle multiple projects simultaneously. Must have excellent interpersonal skills. · Must be PC literate (Microsoft Office) and able to work in multiple database/systems simultaneously. Excellent verbal and written communication skills. · Ability to abide by policies. Maintain regular attendance based on agreed-upon schedule. · Maintain confidentiality and comply with Health Insurance Portability and Accountability Act (HIPAA). · Ability to establish and maintain positive and effective work relationships with coworkers, clients, members, providers and customers. Qualifications Required Education: · Unencumbered license to work as a Registered Nurse in the State of Ohio. · Required Experience: 0-2 year's clinical experience or equivalent combination of education and experience. · Desired Experience: 0-2 years' experience. Additional Information Kind Regards Sumit Agarwal 732-902-2125
    $39k-50k yearly est. 60d+ ago
  • MSL/Sr. MSL, Neurology - Alzheimer's Disease, Southern Ohio- Field based

    Eisai 4.8company rating

    Columbus, OH

    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Builds relationship and demonstrates the clinical outcome and benefits of company products to thought leaders, medical groups, government agencies, key opinion leaders and health systems with drug formularies, consumer-ready medical and dental products. Educates and demonstrates the benefits of key products to clinical professors, teaching-hospital faculty, residents, and students. Provides medical information to internal/external health sources such as the sales force, outside health professions, public, and government. Explores and identifies sites for clinical trial in all stages of development. Coordinates continuing education workshops, seminars, and programs for graduate physicians, pharmacists, and scientists. Responds to unsolicited inquiries to establish and/or further the knowledge and understanding of marketed products and related topics. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS:\ Product/Therapeutic Area Support to Stakeholders · Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding. · Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups. · Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests. · Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested. · Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities. · Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource · Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data · Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives · Serve as technical/scientific subject matter resource to Eisai cross functional partners · Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning. · Ability to lead and motivate team members without a direct reporting relationship Research Support · Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials. · The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: · 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title · Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred · 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting. · Strong broad-based scientific and pharmaceutical knowledge · Clinical trial development and drug launch experience is strongly preferred · Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required. · Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: · Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs. · Committed to the concept of team and working within the framework of the Medical Affairs · Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately. · Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately. · Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs. · Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies. · Interest in leading and participating in projects while effectively balancing field work. · Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them. · Seamlessly adapts to field situations and effectively problem solves within your territory · Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies · Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing · Possesses and maintains a valid driver's license and clean driving record. · Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends. · This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Sr. MSL, Neurology - Alzheimer's Disease, Southern Ohio- Field based is from :$160,100-$210,100Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
    $160.1k-210.1k yearly Auto-Apply 10d ago
  • Manager, Clinical Operations, Monitoring Oversight

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Columbus, OH

    The Manager, Clinical Operations works closely with the OPDC Monitoring Oversight Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight duties as well as escalating issues related to CRO monitoring quality. While focusing on quality and compliance, uses metrics and key performance indicators to drive monitoring oversight activities to achieve timelines and deliverables across the portfolio. Additionally, the Manager, Clinical Operations will support planning, resourcing, contracting, and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager, Clinical Operations will also coordinate reporting and review of CRO related Key Performance Indicators (KPIs) Monitoring Oversight Lead. **Job** **Description** - Manage Monitoring Oversight activities in North America, and other regions as assigned - With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s) - Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks - Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training) - Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead - Review OAV reports and manage timelines and deliverables - Oversee FSP monitoring resources in assigned region(s) as applicable - Support implementation and improvement of monitoring oversight related processes - Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs) - Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management - Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids - Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable - Ensure compliance with clinical systems use and updates - Provide support for internal audit and regulatory inspection activities as applicable - Review study specific monitoring plans and provide feedback prior to implementation - Collaborate with CMC staffing vendors, as applicable - Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget - Other monitoring oversight activities as assigned by OPDC Oversight Lead **Qualifications/** **Required** Knowledge/ Experience and Skills: - Experience managing field-based Clinical Research Associates. - Demonstrated ability to lead teams. - Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit). - Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills. - Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors. - Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations. - Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance. - Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants. - Possess advanced computer skills (e.g., Microsoft applications, etc. - Financial management skills as applicable to oversee initiatives and system expenditures. - Ability to handle and prioritize multiple tasks. - Ability to work effectively in a team/matrix environment. - Ability to travel up to 30% including ground and air travel. Educational Qualifications - 7 years of industry experience and a minimum BA/BS Life Sciences, or equivalent college program, is required. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $107.7k yearly 23d ago
  • Technical Sales Specialist (Trace Elemental Analysis)

    Invitrogen Holdings

    Remote job

    As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Our Chromatography and Mass Spectrometry team develops and manufactures cutting-edge instruments, consumables, and software solutions for analytical sciences and scientific research. Our comprehensive workflow solutions supercharge productivity and efficiency in food and beverage testing, environmental and industrial testing, biopharma QA/QC, toxicology, and anti-doping. Our products are pivotal in scientific research, supporting multiomics, drug discovery, and clinical research, driving advancements in these vital fields. DESCRIPTION: Join our team at Thermo Fisher Scientific as a Product Specialist III, where you'll contribute to revenue growth and customer success through technical sales expertise. You'll represent our portfolio of scientific instruments and solutions, working closely with customers to understand their needs and deliver effective solutions that enable them to make the world healthier, cleaner, and safer. As a technical advisor, you'll develop and maintain strong relationships with key accounts while providing technical expertise across the sales cycle. You'll collaborate with cross-functional teams including sales, marketing, and technical support to implement sales strategies and deliver exceptional customer experiences. MINIMUM REQUIREMENTS: • Master's degree plus 5 years of technical sales experience in relevant scientific instrumentation, laboratory products, or life sciences industry • Preferred Fields of Study: Biology, Chemistry, Biochemistry, Engineering or related discipline • Deep technical knowledge of assigned product portfolio and applications • Strong understanding of laboratory workflows and customer requirements • Demonstrated success in meeting or exceeding sales targets • Excellent presentation and communication skills, with ability to explain complex technical concepts • Experience using CRM systems (e.g., Salesforce) and Microsoft Office Suite • Strong analytical and strategic planning capabilities • Ability to work both independently and collaboratively in a matrix environment • Demonstrated project management and organizational skills • Travel requirements of 50-75% within assigned territory • Valid driver's license and ability to lift/move equipment as needed • Proficiency in English required, additional languages valued for international roles • Strong relationship building and negotiation skills • Ability to analyze market trends and competitive landscape • Experience delivering technical demonstrations and training
    $70k-107k yearly est. Auto-Apply 3d ago
  • LIMS Specialist - REMOTE

    Thorne 3.7company rating

    Remote job

    At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage. Position Summary: The LIMS Specialist supports the daily operation, maintenance, and continuous improvement of the Laboratory Information Management System (LIMS). This role provides hands-on support for system configuration, troubleshooting, validation execution, documentation, and end-user assistance in a cGMP-regulated environment. Supports coordination with the system vendor for system configuration and troubleshooting issues, data reporting, authoring SOPs, and ensuring system cGMP compliance for the Quality Systems and QC Laboratory functions. This is a remote role. Responsibilities * Provides day-to-day Tier 1 support for LIMS users, including issue triage, troubleshooting, and resolution under guidance of senior LIMS staff. Escalates complex issues to senior LIMS staff. * Assists with approved system configuration activities such as test setup, workflows, templates, and master data updates under guidance of senior LIMS staff. * Supports the implementation of new or revised methods, workflows, or processes to meet or improve QA and QC Laboratory operations. * Assists in the updates to outward-facing Certificates of Analysis (OFCOA); supports OFCOA template validation. * Supports improvement initiatives related to laboratory workflows, system usability, and efficiency. * Assists in the creation and maintenance of SOPs, work instructions, and training materials related to LIMS. * Supports the design and implementation of new or revised methods, workflows, or processes to meet or improve QA and QC Laboratory operations. * Serves as Subject Matter Expert (SME) to assist and provide support to end users for new/existing software functions and/or modules as they apply to LIMS (Laboratory Information Management System) and other systems used in QA and Quality Control. * Assists in the updates to outward-facing Certificates of Analysis (OFCOA); supports OFCOA template validation. * Supports Excel data validation. * Supports software validation activities in QA and the QC Laboratories. * Ensures compliance with software testing and validation requirements. * Ensures data integrity standards. * Supports staff training prior to the implementation of new systems, changes and modifications to the systems as needed, with QA/QC Lab Management approval. * Supports software validation activities, including execution of approved IQ/OQ/PQ protocols. * Assists in drafting validation documentation, test scripts, and evidence packages. * Participates in system upgrades, enhancements, and improvement projects as assigned. * Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policies and procedures. * Troubleshoots or carries out actions per scheduled or unscheduled maintenance. What You Need * High school diploma or GED required. * Experience with computer systems with at least one year providing support in a technical environment is required. * Associate or bachelor's degree coursework in Life Sciences, Information Technology, Computer Science, or a related field preferred. * 0-2 years of experience in a laboratory, quality, technical support, or regulated environment preferred. * Prior exposure to LIMS or laboratory systems is a plus but not required. * Experience with programming languages desirable. * Possesses strong analytical skills with demonstrated problem-solving ability. * Works independently with little direction in a fast-paced environment. * Has knowledge of Microsoft products such as Word, Excel, Visio and Power Point as well as the ability to learn other computer system. * Has knowledge or ability to learn of project software (i.e., Go To Meeting, Zoom, Microsoft Team). * Has knowledge or ability to learn scripting and markup languages (i.e., SQL, JavaScript, HTML). * Has knowledge or ability to learn reporting software (i.e., Tableau, Qlik). What We Offer * Competitive compensation * 100% company-paid medical, dental, and vision insurance coverage for employees * Company-paid short- and long-term disability insurance * Company- paid life insurance * 401k plan with employer matching contributions up to 4% * Gym membership reimbursement * Monthly allowance of Thorne supplements * Paid time off, volunteer time off and holiday leave * Training, professional development, and career growth opportunities Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com. THORNE IS AN EQUAL OPPORTUNITY EMPLOYER #LI-SC1
    $36k-52k yearly est. 8d ago
  • Field Clinical Specialist - Shockwave -Dallas, TX - Remote

    8427-Janssen Cilag Manufacturing Legal Entity

    Remote job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: MedTech Sales Job Sub Function: Clinical Sales - Hospital/Hospital Systems (Commission) Job Category: Professional All Job Posting Locations: Dallas, Texas, United States : Job Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times. You must be located in the Dallas area. Essential Job Functions Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. Effectively meet the needs of internal and external customers with a sense of urgency and drive. Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms. Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues. Administrative activities including training to procedures, manage territory travel and budgets. Other duties as assigned. Qualifications Minimum Bachelor's Degree in business, science, nursing or related fields, or equivalent experience. Minimum 2 years' experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required. Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. A history of effective collaboration with regulatory agencies through clinical studies and market releases. Product knowledge including product vigilance and medical device reporting. High attention to detail and accuracy. Computer skills (MS Office products, word processing, spreadsheets, etc.). Finance and budgeting knowledge. Good prioritization and organizational skills. Excellent critical thinking skills. Excellent influencing and negotiation skills. High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. Entrepreneurial “hands-on” experience. Pro-active and “can do” attitude. Ability to consider and accept feedback and suggestions for continuous improvement. Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such. Effective written, verbal and presentation skills with all levels of customers and management. Ability to work in a fast-paced environment while managing multiple priorities Operate as a team and/or independently while demonstrating flexibility to changing requirements. There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Significant travel >50% of time requiring the employee to be effective in a remote manner. Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space. Pay Transparency: Additional Information: The base pay range for this position is $100,000 - plus a strong variable component. The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. This position is eligible for a car allowance through the Company's Fleet program Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ******************************** ) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection
    $100k yearly Auto-Apply 19d ago
  • Senior Associate, Operational Excellence

    Care Access 4.3company rating

    Remote job

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference We are seeking an experienced clinical research associate to assist with the operations and strategic growth of our clinical research sites. The ideal candidate brings a strong background in clinical research management, regulatory compliance, and team development, with a proven ability to drive operational excellence and foster a culture of quality. This role requires a proactive, solutions-oriented professional who can balance day-to-day site operations with long-term business development and staff leadership. The successful candidate will ensure compliance with all applicable regulations, assist with study start-up and enrollment efforts, and cultivate an environment where staff thrive, and studies are executed at the highest standards. How You'll Make An Impact Site Operations Management - Assist with daily site activities acting as the primary point of contact for the site, ensuring appropriate staffing, training, and adherence to SOPs. Maintain compliant facilities and equipment. Leadership & Staff Development: Assist with training and mentoring research staff. Uphold professional development goals and foster a culture of accountability, integrity, and continuous improvement. Work with Manager, Operational Excellence to ensure high staff morale and low turnover rates Regulatory & Compliance Oversight: Promote strict adherence to ICH-GCP, FDA, and local regulations, while maintaining audit readiness across all studies. Assist Manager, Operational Excellence, Operational Compliance, and Quality Assurance Departments with all Care Quality and FDA audits Business Development: Support feasibility assessments through partnership with Manager, Operational Excellence to ensure timely responses to questionnaires, and scheduling of site qualification visits. Study Start-Up & Enrollment Oversight: Support with regulatory packet submissions, and site initiation processes. Work with investigators to meet or exceed patient recruitment and retention goals. Assist with additional projects such as quality improvement initiatives, internal data monitoring ensuring accuracy, integrity, and timely entry of study data, and may represent the site at meetings and industry events. The Expertise Required A minimum of 5 years of clinical research experience, with at least 1-2 years in a supervisory or management role. CRC experience a plus. Hands-on knowledge of ICH-GCP, FDA regulations, and local regulatory requirements. Demonstrated success in study management, study start-up, patient recruitment, and compliance oversight. Budget management, business development, or sponsor/CRO engagement experience is a strong plus. Certifications/Licenses, Education, and Experience: An equivalent combination of education and direct clinical research leadership experience may be considered in place of formal degrees Preferred: Bachelor's degree in a health sciences field (e.g., Nursing, Biology, Pharmacology, Public Health, or related discipline). Minimum of five years Clinical Research experience. How We Work Together Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment. Travel: This role requires up to 50% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of travel required: National Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Walking - 10% Standing - 10% Sitting - 80% Lifting up to 25 lbs - as needed Driving - as needed The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $70k-100k yearly Auto-Apply 3d ago
  • GCP Process Lead, FSP Clinical Compliance

    Invitrogen Holdings

    Remote job

    As the GCP Compliance and Process Lead at Thermo Fisher Scientific, you will play a pivotal role in driving world-class quality and compliance strategies. This is an exceptionally outstanding opportunity to influence and improve our healthcare operations, ensuring flawless execution of regulatory standards. Your expertise will be crucial in determining and successfully implementing advanced quality assurance processes. Role: GCP Process Lead, FSP Dedicated Location: Remote, USA Key Responsibilities Facilitate and manage cross-functional teams' GCP inspection readiness activities throughout the study lifecycle. Embed real-time inspection readiness strategies into daily operations, collaborating with study teams. Provide just-in-time guidance on key operating model processes and required documentation, prioritizing real-time inspection readiness. Manage and guide teams on inspection readiness planning, developing and maintaining readiness plans and tools. Facilitate the development of key inspection deliverables, including functional presentations and study team preparation for audits. Ensure high-quality deliverables for global studies by guiding adherence to operational processes and documentation. Champion proactive prioritization of inspection readiness, focusing on GCP process excellence. Engage with subject matter experts in inspection readiness activities and study-level risk assessments. Coordinate and manage TMF performance and processes, ensuring compliance and inspection readiness. Lead and participate in meetings for assigned projects, ensuring effective communication and addressing customer concerns. Maintain project management documentation, including plans, timelines, and progress reports. Coordinate activities to enable study team readiness for internal audits and regulatory inspections. Manage functional teams during inspections, collaborate with SMEs, and ensure timely follow-up Qualifications Good understanding of clinical trial processes related to sponsor and CRO activities, including but not limited to sponsor oversight, issue management, site management, and clinical monitoring Preferred experience with inspection preparation, including hands on regulatory inspection activities Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field; with at least two years specifically supporting clinical Quality & Compliance Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes Proven awareness of sponsor oversight requirements and regulations Experience with CROs and outsourced clinical trial activities, sponsor experience preferred Experience in problem solving, negotiations, and collaborative team building and other collaborators is required Strong understanding of regulatory requirements within clinical trials, industry standards, and related documentation needs Bachelor's degree preferred or commensurate with experience Must be able to efficiently apply computer software programs like Microsoft Office for general use, project management, and presentations Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel Domestic/international travel (5-20%) may be required Inclusion and Collaboration At Thermo Fisher Scientific, we value diverse experiences, backgrounds, and perspectives. Our inclusive culture fosters collaboration and innovation, empowering each team member to contribute to our mission of advancing science and healthcare.
    $71k-109k yearly est. Auto-Apply 60d+ ago
  • Statistician Intern (Summer 2026 - Temporary)

    Penumbra 4.4company rating

    Remote job

    General SummaryUnder the direction of a statistics manager or above, the Statistics Intern Temp assists with the implementation of clinical research projects through statistical analysis and data review. This role supports the biostatistics, data management, and clinical research teams and provides an opportunity to increase clinical knowledge through familiarity with Good Clinical Practices (GCP), FDA regulations, statistical principles, and guidelines of other regulatory health agencies. We will be accepting resumes for the Summer 2026 statistician intern opportunity until February 20, when we will begin screening potential candidates. We anticipate scheduling final interviews mid-March and will extend an offer before the end of the same month. This role will last approximately 3 months, with the potential to extend beyond the summer. This role is not open to external agencies. Specific Duties and Responsibilities•Work with an experience statistician on one or two statistical topics*•Generate data tables, figures, and listings for clinical study reports *•Utilize and select appropriate statistical methods for the analysis of clinical study data *•Write and document data analysis programs *•Set up study folders and programming environment *•Generate and validate analysis datasets *•Perform complex data checking *•Interface with co-workers within Clinical Research on trial data review and reporting•Adhere to the Company's Quality Management System (QMS) as well as domestic andglobal quality system regulations, standards, and procedures. *•Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *•Perform in-house administrative tasks in assigned projects.•Perform other work-related duties as assigned. *Indicates an essential function of the role Position QualificationsMinimum education and experience:•Master's degree in Statistics, Mathematics, or related field with 1+ years of data analysis experience, or an equivalent combination of education and experience. Additional qualifications:•PhD (earned or in process) highly preferred.•Excellent written, verbal, and interpersonal communication skills.•Technology adept and strong proficiency with MS Suite and other standard office software.•Proficiency with SAS or other statistical programs strongly preferred. Specific Areas of Experience and Interest•Longitudinal analysis and missing data imputation.•Meta-analysis.•Actigraphy data/wearable device data. Working Conditions•General office environment.•May have business travel from 0% - 15% to research sites may be required•Potential exposure to blood-borne pathogens.•Requires some lifting and moving of up to 25 pounds.•Must be able to move between buildings and floors.•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.•Must be able to read, prepare emails, and produce documents and spreadsheets.•Must be able to move within the office and access file cabinets or supplies, as needed.•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. Compensation: $30/hour - $50/hour Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
    $30 hourly Auto-Apply 3d ago
  • Cardiologist - Remote Imaging Consultant

    Hawthorne Health

    Remote job

    We are seeking a highly skilled Cardiologist Consultant specializing in Imaging Review to provide expert analysis and interpretation of cardiac imaging studies. This role involves collaborating with multidisciplinary teams to ensure accurate diagnosis and optimal patient care. The ideal candidate will possess extensive experience in cardiology, medical imaging, and advanced diagnostic techniques, contributing to clinical research and quality improvement initiatives within a hospital or outpatient setting. The position offers an opportunity to work with cutting-edge technology and contribute to the advancement of cardiac care.Requirements Review and interpret cardiac imaging studies, including echocardiograms with precision. Create final report of findings and upload into StudyCast imaging platform. Participate in multidisciplinary case discussions, providing expert insights into complex cardiac conditions. Contribute to clinical research projects related to cardiology and imaging modalities. Maintain compliance with HIPAA regulations and ensure confidentiality of patient information. Support quality assurance initiatives by ensuring imaging protocols meet clinical trial standards and best practices. Qualifications MD licensed in Puerto Rico. Board-certified or eligible in Cardiology with subspecialty training in Cardiac Imaging or equivalent experience. Extensive knowledge of medical imaging techniques including echocardiography, CT, MRI, nuclear medicine, and interventional radiology procedures.
    $71k-100k yearly est. Auto-Apply 60d+ ago
  • Director, Safety Data & Systems

    Argenx

    Remote job

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Director, Safety Data & Systems, GPS Operations oversees and coordinates deliverables related to Global Patient Safety (GPS) Safety Data Management and Safety Systems Maintenance, and ensures high quality data provision for Safety Signal Management, Risk Management and Safety Evidence generation. The Director will also collaborate and co-create within argenx as well as with Safety vendors and argenx business partners, and ensure compliance with regulatory requirements regarding Safety data processing and reporting with high technical and operational standards. ROLES AND RESPONSIBILITIES Oversee and coordinate the maintenance of and updates to the global safety database for all argenx products, new programs including reporting rules and system validation Lead GPS collaboration with Safety vendor on initial and ongoing Safety database configurations and assess impact and risk on changes applied Develop and implement procedural documents such as Job Aides, Work instructions, forms and templates related to safety data management and systems maintenance Collaborate and co-create with global argenx functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical roadmap, setup and operations Keep team and self updated on applicable regulatory and PV tech guidelines and regulations and provide targeted trainings as applicable Focus areas would be but not limited to Safety operations and process optimization, Vendor management and third-party oversight, Drug safety database and systems administration, Regulatory inspections/audits and quality compliance and Cross-functional collaboration for risk management and reporting. Complete additional task and projects as assigned by line manager or Head of GPS SKILLS AND COMPETENCIES Advanced knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan) Advanced computer skills in all current office applications including PowerPoint, Visio Expert level skill in Excel usage required, experience with SQL is a plus Advanced proficiency in Safety Database systems (e.g. Argus) and other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems). Advanced proficiency in electronic systems and dashboards commonly used for data visualization and analysis Knowledge of workflow based case processing and the MedDRA dictionary Robust understanding of the quality management processes, metrics and KPIs Advanced project management skills to complete multiple complex deliverables within tight timelines Proven ability to communicate effectively and collaborate successfully across functions and with vendors Fluent communication in written and spoken English required Proven ability to work independently with minimal oversight and prioritize effectively Ability to function effectively in a team environment Ability to assume Line Management responsibility and oversee functional teams EDUCATION, EXPERIENCE AND QUALIFICATIONS At least Bachelors' degree (or country equivalent) in life sciences / Information technology or other relevant field required Minimum of 10 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 5 years of proven experience working in Safety database setup and maintenance. Proven experience of the usage of advanced technology and tools (tracking systems, dashboards) used in Safety / PV, pre-and post-marketing. Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills. #LI-remote For applicants in the United States: The annual base salary hiring range for this position is $192,000.00 - $264,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com . If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at **************** . Only inquiries related to an accommodation request will receive a response.
    $68k-107k yearly est. Auto-Apply 19d ago
  • Intern - Clinical Trial Program Manager

    Labcorp 4.5company rating

    Remote job

    At Labcorp, we believe in the power of science to change lives. We are nearly 70,000 people across 100 countries who are harnessing science for human good. Our work combines unparalleled diagnostic laboratories, drug development capabilities and commercial innovations. Together, we fuel scientific breakthroughs and deliver more than 160 million medical test results that help guide treatment decisions, accelerate patient care and change lives. Join us in our pursuit of answers. Labcorp 2026 Global Internship Program Exciting Internship Opportunity - Clinical Trial Program Manager | Remote Join Labcorp's 2026 Global Internship Program and take the first step toward a meaningful career in healthcare innovation! We're looking for motivated students to be part of a dynamic 12-week paid internship where you'll work on impactful projects and gain real-world experience, all while supporting our mission to improve health and improve lives. Internship 2026 Dates: May 18, 2026 - August 7, 2026 About the Program As a Labcorp intern, you'll be immersed in hands-on work that complements your academic background. In addition to your project work, you'll gain valuable exposure to Labcorp's global business, culture, and leadership through: Enterprise-wide learning experiences that introduce you to key business functions across Labcorp Leadership exposure and visibility, including direct interaction with senior leaders An immersive, in-person intern event June 2-4, 2026, designed to connect you with peers and deepen your understanding of our mission Senior leader speaker sessions offering insights into strategy, innovation, and career growth Continuous opportunities to connect and grow, from intern cohort communication channels and LinkedIn Learning resources to professional development sessions and storytelling opportunities that highlight your internship journey Connection to Labcorp's inclusive culture through engagement with our employee resource groups (ERGs)and values-driven community initiatives Dedicated mentoring connections to guide your growth, provide career advice, and support your internship journey Internship Details Duration: 12 weeks, full-time Dates of Internship: May 18, 2026 - August 7, 2026 Location: Remote or Durham, NC Compensation: Paid internship; relocation assistance available for qualified candidates Eligibility: Preferred candidates are rising juniors and seniors (Dec 2026 through June 2028 graduation) who are currently enrolled in a relevant degree program; however, all current students pursuing related studies are encouraged to apply. Why Labcorp? In 2025, we welcomed over 300 interns across our global offices. As part of the 2026 cohort, you'll join a diverse community of future leaders working to shape the future of diagnostics, biopharmaceutical lab services, corporate functions, and healthcare delivery. Ready to make a difference? Apply now to launch your career and create real impact for patients worldwide. #FutureofLabcorp About the Team: The Biopharma Laboratory Services (BLS) Digital Products team creates innovative digital solutions that transform clinical trial and drug development. We deliver measurable value to key customer segments by enhancing operational efficiency, elevating user experience, and driving superior business outcomes. Internship Assignment Summary: Contribute to product team initiatives that improve the use of protocol and lab documents during clinical trials and support downstream analytical services. Review clinical trial protocols and accurately document protocol metadata into source systems, including translating lay clinical indications into standardized codes (e.g., ICD). Develop expertise in protocol documentation and lab manual structure/ontology to support product requirements gathering Support creation of clinical trial examples and test cases for machine learning training, including generating example lab queries and leveraging AI tools to expand datasets. Education/Qualifications/Skills: Education Requirements Currently enrolled in a graduate program (Master's or Ph.D.) in Clinical Research, Public Health, Biomedical Sciences, Pharmacy, Nursing, or a related field. Coursework or training in clinical trial design, protocol development, or medical terminology preferred. Experience Requirements Prior experience writing, reviewing, or interpreting clinical trial protocols (academic, industry, or internship experience acceptable). Familiarity with clinical trial lab manuals, including structure and common laboratory procedures. Working knowledge of clinical and medical terminology, with ability to translate lay terms into standardized codes using available resources (e.g., ICD10). Exposure to clinical data standards (e.g., CDISC, OMOP) or ontology concepts. Experience with data entry and documentation in clinical systems preferred. Interest or experience in AI/ML applications in clinical research (e.g., creating test cases, generating examples) is desirable. Application Window: 1/23/26-2/6/26 Pay Range: $35-$40/hr All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $35-40 hourly Auto-Apply 9d ago
  • Full-Stack Software Developer (Remote)

    Tilda Research

    Remote job

    Why work at Tilda? Create a product which will redefine medical innovation: Tilda is a fully-integrated clinical trial network. We help pharma innovators leverage our unprecedented data insights, to better execute their clinical trial programs. Thus, we have the chance to institute a meaningful impact on millions of lives. You can help us realize that goal. Work with some of the best engineers in the world: We are a team of repeat founders, who have built companies in cloud infrastructure, mobile security and life sciences. Our small team of founding engineers are passion driven, and have a long history of achievement. Tackle our most interesting and impactful problems: Our team is still small, and people wear many hats. You'd jump between product, marketing, internal tools, process - participating in every phase from inception to implementation. Absolutely no boredom. Join us at a magical time: We've hit revenue growth and product-market fit, which gives us a huge green field to work with. You'd join at the perfect time to shape what we build and how we grow. About this Role So, what will you do as a Software Developer? You will work on full-stack application engineering relevant to various clinical workflows Build automation tools to enable streamlined workflows across trial execution Work on data ETL pipelines, and help improve our AI engine to better organize and process our clinical data You will interact with our product and clinical team to design and implement features which could help improve above mentioned workflows You would be successful as a candidate if... You have good understanding of foundational computer science concepts like design patterns, data structures, web architecture and algorithms You are proficient with at-least one web-focused programming language like Python, JavaScript or Ruby You understand how to build and use API interfaces to create appropriate software interfaces You can readily learn most technologies as you go. To you, technologies are about tools and tradeoffs, not an ideology. You have an opinionated personality with excellent written skills. We are a remote team, and your ability to write your thoughts out is critical. You care about the business implications of anything you build. You're not just going after cool stuff - you understand the balance between craft, speed, and the bottom line. Requirements Bachelors degree in Computer Science or Engineering Fluency with Python, Ruby or Javascript Excellent written English communication skills Vocal and opinionated on your design and implementation Focus on clean code and documentation Note: We are a remote-first company and are looking for team members who are comfortable with remote work. We are open to any region / timezone as long as you are self-motivated and can demonstrate a strong work ethic. About Tilda Research We are a clinical trial network built from the ground up, suitable for the modern era of medical innovation. Our passion lies in enabling faster and safer access to life saving treatments for patients. Through our technology enabled network, we are accelerating the process of medical innovation and research across multiple treatment modalities. We work with a diverse set of customers, from large pharma to startup biotech, helping them with meet their clinical trial objectives. Our team deals with a wide range of problems across technology, system integration, automation, research delivery and health care management. Our team consists of of experts in systems engineering, machine learning, clinical research and physicians. We are looking for self-motivated individuals looking to join a fast-paced startup. We are a San Francisco based company, which believes in remote-first teams. We have presence in several locations in the US and Asia. Benefits Amazing Team Impactful work with tangible social benefits Remote first Flexible PTO and hours
    $96k-132k yearly est. 60d+ ago
  • Policy Analyst

    Aptive 3.5company rating

    Remote job

    Aptive seeks an experienced Analyst to provide integrated analytical, policy, clinical, and reporting support across the Veteran Directed Care (VDC) and Caregiver Support Program (CSP). This role supports readiness reviews, program implementation, performance monitoring, training development, and data-driven decision-making in alignment with VHA Office of Geriatrics and Extended Care (GEC) objectives. The Analyst collaborates closely with Government stakeholders, project management staff, and subject-matter experts to ensure deliverables are accurate, timely, and compliant with applicable federal and VA requirements. Primary Responsibilities The Analyst conducts policy and clinical research related to self-directed care models, caregiver support programs, and long-term services and supports (LTSS); supports readiness reviews through evaluation of programmatic and financial documentation; and develops written products including policy briefs, VACO and VAMC briefings, targeted and topical analysis reports, implementation materials, and training content. The role also includes data collection, validation, analysis, and reporting functions such as performance tracking, trend identification, survey analysis, and preparation of monthly progress reports and ad hoc analytical products in response to emergent program needs. Minimum Qualifications 3+ years of relevant experience supporting federal, state, or large-scale healthcare, caregiver, or long-term services and supports (LTSS) programs. Bachelor's degree in Public Health, Health Administration, Social Work, Policy, Health Sciences, Data Analytics, or a related field Demonstrated experience conducting policy analysis, clinical or programmatic research, and developing written deliverables for government or healthcare audiences Experience analyzing qualitative and/or quantitative data and producing clear, well-organized reports Strong written and verbal communication skills, including the ability to translate complex information into actionable insights Proficiency with Microsoft Office applications (Word, Excel, PowerPoint), including data analysis and reporting functions Ability to manage multiple priorities, meet deadlines, and work independently in a dynamic environment Desired Qualifications Experience supporting or working with Veteran Directed Care (VDC), Caregiver Support Program (CSP), PCAFC, PGCSS, or similar self-directed or caregiver-focused programs Familiarity with VA, federal, and state regulations related to caregiver support, LTSS, and home- and community-based services Experience supporting readiness reviews, organizational assessments, or compliance evaluations Advanced data analysis or reporting experience, including trend analysis, dashboards, or survey data synthesis Experience developing training materials, field guides, or implementation resources for healthcare or social service programs Prior experience working with or supporting the Department of Veterans Affairs or other federal healthcare agencies About Aptive Aptive partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. Based in Alexandria, Virginia, we support more than a dozen agencies including Veterans Affairs, Transportation, Defense, Homeland Security and the National Science Foundation. We specialize in applying technology, creativity and human-centered services to optimize mission delivery and improve experiences for millions of people who count on government services every day. Founded: 2012 Employees: 300+ nationwide EEO Statement Aptive is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, color, national origin, religion, creed, sex, sexual orientation, gender identity, marital status, parental status, veteran status, age, disability, or any other protected class. Veterans, members of the Reserve and National Guard, and transitioning active-duty service members are highly encouraged to apply.
    $60k-84k yearly est. Auto-Apply 5d ago
  • Project Leadership - Biotech (clinical trials) - Oncology - Home Based - (Future Needs)

    Parexel International 4.5company rating

    Remote job

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    $98k-139k yearly est. Auto-Apply 37d ago
  • Project Manager (Clinical Research)

    Celerion 4.2company rating

    Remote job

    Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity to lead projects creating life-saving treatments? If so, we want to meet you! Celerion seeks a full-time, experienced Global Project Manager to join our team. This critical role is accountable for project deliverables and client satisfaction, serving as a consistent point of contact for internal and external clientele from the beginning to the end of the project life cycle. The position requires a high level of leadership, collaboration, and relationship-building to ensure optimal project success. Please note: This role may be located in our Tempe, AZ office, Lincoln, NE office, or based remotely (working from home anywhere in the US ). Essential Functions:Manages multiple clients and their associated projects, fostering relationships with assigned clientele Confirms each project's scope in conjunction with the client and operational teams to ensure adherence to contractual scope, timelines and budget for all team members Engages assigned team and functional managers in the development, assignment and prioritization of work based on the project's needs, taking corrective action with Operations as appropriate to control project scope and cost Fosters high-level of communication by conducting frequent project meetings, initiated at project inception and continuing through project closeout Creates or reviews and maintains project-related documentation including: RFIs, Budgets, Meeting Minutes, Timelines, Client Isms, Issues and Risk Lists, Change Requests, etc.Implements change management where appropriate to alleviate bottlenecks, improving processes and procedures to enhance the efficiency and effectiveness of the organization Updates relevant databases required to maintain and report on current project statuses and overall financial reporting Hosts client visits and conducts facility tours Requirements: Bachelor's degree required (degree emphasis in life science discipline preferred) Requires high-level skills in the areas of organization, multi-tasking, relationship-building, communication, judgment, problem-solving, persuading and negotiating Minimum 2 years of Clinical Research industry experience is highly preferred 3 years Phase I Project Management experience preferred #LI-Remote Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
    $71k-112k yearly est. Auto-Apply 60d+ ago
  • Project Manager II: Late Phase Oncology; ISR/CO Study Manager (Sponsor Dedicated/ US Remote)

    Syneos Health Clinical Lab

    Remote job

    Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Project Manager II: Late Phase Oncology; ISR/CO Study Manager (Sponsor Dedicated/ US Remote) Make an Impact Where It Matters Most Are you an experienced ISR/CO Study Manager ready for a role where your expertise directly accelerates meaningful oncology research? At Syneos Health, you'll step into a high‑visibility, sponsor‑dedicated position supporting a large portfolio of Investigator Sponsored Research (ISR) and collaborative (CO) studies. You'll partner closely with Medical Affairs and principal investigators to drive studies to completion and support their path to publication. This isn't traditional project management-this is customer‑facing scientific study management at scale, where strong communication, organization, and oncology expertise truly matter. What You'll Own & Lead: 🔹 ISR/CO Study Oversight & Execution Manage a high volume of global ISR and collaborative studies, ensuring compliance, scientific integrity, and timely progression. Serve as the primary operational contact for principal investigators and study teams, providing ongoing support from start‑up through completion. Ensure accurate tracking of study status, milestones, documentation, and deliverables across the ISR/CO portfolio. Partner with Medical Affairs to facilitate study progress, troubleshoot issues, and remove barriers to execution. Support investigators through the publication process, including data requests, review timelines, and coordination with internal stakeholders. 🔹 Financial & Risk Management Oversee study budgets, financial tracking, and forecasting for assigned ISR/CO programs. Monitor potential risks related to funding, operations, timelines, and compliance; escalate and mitigate proactively. Review and approve site/vendor invoices and support client billing with accuracy and accountability. 🔹 Client, Investigator & Cross‑Functional Partnership Represent Syneos Health as a key point of contact in this high‑visibility, customer‑facing role. Build strong working relationships with Medical Affairs, sponsors, and investigators to ensure alignment and clarity of expectations. Lead internal/external meetings with confidence-driving communication, organization, and follow‑through. 🔹 Training, Knowledge & Thought Support Participate in protocol‑specific onboarding and study‑related training. Continue to deepen your expertise in oncology and late‑phase research. Share knowledge and best practices with peers and cross‑functional teams to elevate study execution standards. What You Bring: MUST HAVE: Prior experience managing ISR/CO studies within a pharmaceutical or CRO environment. Oncology experience required, ideally late‑phase. Strong understanding of ICH GCP, ethics, regulatory expectations, and clinical research operations. Exceptional communication, organization, and time management skills-this role is highly visible and investigator‑facing. Ability to manage multiple simultaneous studies, prioritize effectively, and work independently. Proficiency in MS Office and comfort working in a dynamic, fast‑paced environment. Why This Role Rocks: ✨ A uniquely collaborative environment where your voice and expertise are valued. ✨ Opportunities for ongoing learning, mentorship, and career growth. ✨ High visibility with both sponsor and investigators. ✨ Direct impact on meaningful oncology research and scientific publications that reach patients worldwide. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $95,000.00 - $175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
    $47k-89k yearly est. Auto-Apply 16d ago
  • Staff Clinical Informaticist

    Teladoc Health Medical Group 4.7company rating

    Remote job

    Join the team leading the next evolution of virtual care. At Teladoc Health, you are empowered to bring your true self to work while helping millions of people live their healthiest lives. Here you will be part of a high-performance culture where colleagues embrace challenges, drive transformative solutions, and create opportunities for growth. Together, we're transforming how better health happens. Summary of Position: The Staff Clinical Informaticist supports the integration, management, and optimization of clinical data systems to enhance virtual care delivery and clinical quality at Teladoc Health. This role focuses on leveraging modern data platforms and electronic medical records (EMRs) to drive data-driven decision-making, support clinical workflows, and ensure the integrity and utility of clinical information. The ideal candidate should have a strong clinical background, be detail-oriented, collaborative, and eager to learn, with hands-on experience in athena One EMR, Athena Data View, Snowflake, First Databank, and Cerner Multum. This role sits at the exciting intersection of clinical workflows, EMR optimization, and data-driven quality improvement. You will play a pivotal part in shaping the everyday experience of our clinicians-making Athena and API interfaces smoother, smarter, and more intuitive. Working closely with clinicians, quality leaders, and the training team, you will help design robust workflows, enhance documentation, and ensure high‑quality data that drives better patient care. Essential Duties and Responsibilities EMR Optimization & Clinician Workflow Support Under the guidance of senior clinical informatics team members, support the front‑end optimization of EMRs and interoperable clinical support applications to drive quality improvement and patient safety initiatives, enhance provider efficiency, and advance virtual care clinical research Collaborate with clinical quality informatics, clinical operations, and the training teams to design, refine, and maintain workflows and documentation templates that support clinical practice Troubleshoot and resolve workflow and data issues that impact clinicians, particularly related to gaps in care activities and quality workflows Clinical Data Design & Quality Improvement Assist in the design, implementation, and maintenance of clinical data solutions leveraging clinical databases to support quality improvement and enterprise reporting Work with key stakeholders to develop, monitor, and update clinical quality and operational KPIs Participate in the creation and maintenance EMR reporting dashboards and clinical analytics that surface key quality and safety insights Integration, Migration & Data Harmonization Support the integration and optimization of EMRs and interoperable clinical support applications, including data extraction, transformation, and loading processes Assist with data migration from legacy EHR systems to current platforms, ensuring data integrity and clinical usability Work closely with clinicians and clinical quality experts to harmonize clinical data with standard medical terminologies (ICD‑10, CPT, SNOMED, LOINC, RxNorm, NDC, and related value sets) Workflow Innovation & Documentation Excellence Contribute to the design and continuous refinement of clinical workflows that improve provider experience, efficiency, and support high‑quality clinical documentation EMR Optimizations : Design, implementation, and maintenance Clinical Decision Support Tools : Development (rule authoring) and maintenance Enhance data quality and efficiency by ensuring documentation templates capture structured, meaningful clinical information needed for quality programs and reporting The time spent on each responsibility reflects an estimate and is subject to change dependent on business needs. Supervisory Responsibilities: No Required Qualifications: Bachelor's degree in health informatics, information systems, or a related field, or equivalent experience. At least 2 years of direct clinical informatics experience, including EMR optimization, configuration, data extraction, and compendium management, particularly in ambulatory settings 1+ years of hands-on experience with Snowflake and Data View, or equivalent, in a health care setting, particularly supporting Quality and Safety process improvement projects Minimum 2 years of experience coding SQL queries in a clinical environment Proficiency with data analytics and visualization tools such as Power BI and Tableau Familiarity with First Databank and Multum Rx compendium management and maintenance Familiarity with drug formulary management and maintenance Strong understanding of healthcare data privacy and security standards (e.g., HIPAA) Exemplary analytical, problem-solving, and organizational skills Excellent written and verbal communication skills Ability to work collaboratively in a highly matrixed, fully remote, cross-functional team environment. Preferred Qualifications: At least 3 years of direct patient care experience Master's degree in clinical informatics or related discipline Deep experience with athena One EMR Experience supporting quality improvement or clinical analytics projects Experience in start-up or corporate virtual care/telehealth environments This is a fully remote role within the U.S. Occasional ( The base salary range for this position is $130,000 - $160,000. In addition to a base salary, this position is eligible for a performance bonus and benefits (subject to eligibility requirements) listed here: Teladoc Health Benefits 2026. Total compensation is based on several factors including, but not limited to, type of position, location, education level, work experience, and certifications. This information is applicable for all full-time positions. As part of our hiring process, we verify identity and credentials, conduct interviews (live or video), and screen for fraud or misrepresentation. Applicants who falsify information will be disqualified. Teladoc Health will not sponsor or transfer employment work visas for this position. Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future. Why join Teladoc Health? Teladoc Health is transforming how better health happens. Learn how when you join us in pursuit of our impactful mission. Chart your career path with meaningful opportunities that empower you to grow, lead, and make a difference. Join a multi-faceted community that celebrates each colleague's unique perspective and is focused on continually improving, each and every day. Contribute to an innovative culture where fresh ideas are valued as we increase access to care in new ways. Enjoy an inclusive benefits program centered around you and your family, with tailored programs that address your unique needs. Explore candidate resources with tips and tricks from Teladoc Health recruiters and learn more about our company culture by exploring #TeamTeladocHealth on LinkedIn. As an Equal Opportunity Employer, we never have and never will discriminate against any job candidate or employee due to age, race, religion, color, ethnicity, national origin, gender, gender identity/expression, sexual orientation, membership in an employee organization, medical condition, family history, genetic information, veteran status, marital status, parental status, or pregnancy). In our innovative and inclusive workplace, we prohibit discrimination and harassment of any kind. Teladoc Health respects your privacy and is committed to maintaining the confidentiality and security of your personal information. In furtherance of your employment relationship with Teladoc Health, we collect personal information responsibly and in accordance with applicable data privacy laws, including but not limited to, the California Consumer Privacy Act (CCPA). Personal information is defined as: Any information or set of information relating to you, including (a) all information that identifies you or could reasonably be used to identify you, and (b) all information that any applicable law treats as personal information. Teladoc Health's Notice of Privacy Practices for U.S. Employees' Personal information is available at this link .
    $130k-160k yearly Auto-Apply 17d ago
  • Manager, Epic Revenue Cycle Applications - Business Applications/Information Solutions (Remote)

    MUSC (Med. Univ of South Carolina

    Remote job

    The Manager, Epic Revenue Cycle Applications reports to the Director, Business Applications as part of the MUSC Associate CIO Applications team supporting MUSC's clinical, research, and academic missions. This role provides oversight and leadership of the Business applications team and for the implementation, monitoring, and maintenance of all applications within the portfolio. This role manages the people, process, and technology components of designated Business applications including but not limited to the following: Epic Resolute Hospital Billing and Claims, Epic Resolute Professional Billing and claims, as well as the Epic Health Information Management. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type Regular Cost Center CC005304 SYS - IS Revenue Cycle & Epic HIM Pay Rate Type Salary Pay Grade Health-32 Scheduled Weekly Hours 40 Work Shift The Manager, Epic Revenue Cycle Applications reports to the Director, Business Applications as part of the MUSC Associate CIO Applications team supporting MUSC's clinical, research, and academic missions. This role provides oversight and leadership of the Business applications team and for the implementation, monitoring, and maintenance of all applications within the portfolio. This role manages the people, process, and technology components of designated Business applications including but not limited to the following: Epic Resolute Hospital Billing and Claims, Epic Resolute Professional Billing and claims, as well as the Epic Health Information Management. Additional Job Description Required Education/Skills/Work Experience: A bachelor's degree in a technical discipline, business or healthcare administration, or related field required; master's preferred. Ten (10) years of experience supporting clinical information systems may be considered in lieu of a bachelor's degree. A minimum of five (5) years' direct experience delivering and supporting healthcare systems/applications. Required experience/skills: * Strong interpersonal and leadership skills; * Proven experience building stakeholder relations and customer service; * Ability to research and develop a strategy to grow teams and manage applications; * Strong communication and presentation and communication (written/verbal) skills. * Demonstrated expertise implementing and/or upgrading an integrated electronic health record (EHR) Preferred experience/skills: * Experience with Epic with at least one Epic certification; * Other related certifications to include PMP, ITIL, Six Sigma, Informatics; * Patient engagement experience. Physical Requirements * Mobility & Posture * Standing: Continuous * Sitting: Continuous * Walking: Continuous * Climbing stairs: Infrequent * Working indoors: Continuous * Working outdoors (temperature extremes): Infrequent * Working from elevated areas: Frequent * Working in confined/cramped spaces: Frequent * Kneeling: Infrequent * Bending at the waist: Continuous * Twisting at the waist: Frequent * Squatting: Frequent * Manual Dexterity & Strength * Pinching operations: Frequent * Gross motor use (fingers/hands): Continuous * Firm grasping (fingers/hands): Continuous * Fine manipulation (fingers/hands): Continuous * Reaching overhead: Frequent * Reaching in all directions: Continuous * Repetitive motion (hands/wrists/elbows/shoulders): Continuous * Full use of both legs: Continuous * Balance & coordination (lower extremities): Frequent * Lifting & Force Requirements * Lift/carry 50 lbs. unassisted: Infrequent * Lift/lower 50 lbs. from floor to 36": Infrequent * Lift up to 25 lbs. overhead: Infrequent * Exert up to 50 lbs. of force: Frequent * Examples: * Transfer 100 lb. non-ambulatory patient = 50 lbs. force * Push 400 lb. patient in wheelchair on carpet = 20 lbs. force * Push patient stretcher one-handed = 25 lbs. force * Vision & Sensory * Maintain corrected vision 20/40 (one or both eyes): Continuous * Recognize objects (near/far): Continuous * Color discrimination: Continuous * Depth perception: Continuous * Peripheral vision: Continuous * Hearing acuity (with correction): Continuous * Tactile sensory function: Continuous * Gross motor with fine motor coordination: Continuous * Selected Positions: * Olfactory (smell) function: Continuous * Respirator use qualification: Continuous * Work Environment & Conditions * Effective stress management: Continuous * Rotating shifts: Frequent * Overtime as required: Frequent * Latex-safe environment: Continuous If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: ***************************************
    $98k-125k yearly est. 16d ago

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