Medical Director (remote)
Viewfi
Remote job
Reports Jointly To: Chief Executive Officer and Chief Medical Officer Clinical Specialty: MD, Board Certified in Sports Medicine (primary board specialty flexible) ViewFi is a nationwide virtual musculoskeletal (MSK) practice bringing high-quality orthopedic, sports-medicine, and physical-therapy care directly to patients in both traditional and non-traditional markets. We serve a diverse set of partners including personal injury/med-legal groups, self-insured employers, risk-based payers, and digital health collaborators in the sports and fitness markets through technology enabled, evidence-based clinical care. We are redefining what excellent MSK care looks like in a virtual environment. Position Summary The Medical Director will serve as the clinical leader of ViewFi's physician team and a core partner to our physical therapy, product, operations, and business teams. This role requires a practicing, board-certified Sports Medicine physician who can balance patient care with 30-40% administrative/leadership responsibilities. The Medical Director will ensure clinical excellence, maintain high-quality and consistent clinical pathways, represent ViewFi as the medical voice of the organization, and advance the science and evidence behind virtual MSK care. Key Responsibilities Clinical Leadership & Oversight Lead, oversee, and support the national team of physicians delivering virtual MSK care. Maintain and update clinical pathways, treatment standards, and practice guidelines across all ViewFi service lines. Partner closely with the Physical Therapy leadership team to ensure integrated, cohesive care between MDs and PTs. Ensure consistent, high-quality clinical documentation, coding accuracy, and compliance across markets. Oversee peer review, quality assurance activities, and clinical performance metrics. Participate in recruitment, onboarding, and ongoing development of new clinicians. Patient Care (70-80%) Actively see patients in a virtual setting, providing MSK consults and follow-ups. Model best-in-class virtual care workflows and contribute to continuous improvement of the patient experience. Support escalated or complex cases requiring senior clinical judgment. Strategic & Administrative Leadership (20-30%) Serve as the medical voice of ViewFi at conferences, webinars, panels, and partner meetings. Collaborate with executive leadership on product development, new service lines, geographic expansion and clinical innovation initiatives. Guide medical input for payers, partners, self-insured employers, and med-legal groups. Participate in strategic planning related to national expansion, licensure strategy, and resource allocation. Work cross-functionally with operations and technology teams to enhance clinical workflows. Provide medical insight and feedback on ViewFi's technology roadmap, including clinical decision support, AI integration, and general telehealth tools. Research, Publishing & Thought Leadership Lead or collaborate on clinical research demonstrating the efficacy of virtual MSK care, including both MSK MD consults and virtual PT. Publish and present outcomes, case series, and efficacy studies at relevant medical and industry conferences. Help build ViewFi's reputation as the leader in evidence-based virtual MSK care. Quality, Compliance & Risk Management Ensure the practice meets state and federal clinical guidelines, telehealth regulations, and licensure requirements. Maintain oversight of clinical incident review processes, risk-mitigation protocols, and outcome tracking. Drive continuous improvement in clinical quality, patient safety, and service reliability. Qualifications MD with Board Certification in Sports Medicine (primary board: FM, IM, EM, PM&R, etc. is flexible). Multi-state licensure required; willingness to pursue additional licensure required. Minimum 10 years of clinical experience; virtual care experience strongly preferred. Demonstrated leadership experience in a clinical or medical director role. Strong collaboration skills with PTs, operational teams, and cross-functional partners. Excellent communication and presentation skills; comfortable representing ViewFi publicly. Passion for virtual care, musculoskeletal medicine, and innovative delivery models. What We Offer Opportunity to lead a national MSK practice at the forefront of technology enabled virtual healthcare Collaborative environment with clinical and operational teams aligned around quality care and aggressive growth Competitive compensation with protected administrative time Support for conference travel, research, publishing, and clinical innovation Commitment to clinical excellence, patient outcomes, and provider support$174k-281k yearly est. 3d agoCare Coordinator I
Integrated Resources
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+ agoTechnical Sales Specialist (Northeast)
Research & Diagnostic Systems
Remote job
By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Pay Range: $95,900.00 - $157,700.00 We are looking for a Technical Sales Specialist to join the Lunaphore sales team, with a primary focus on selling high-end spatial biology capital equipment, as well as associated services, consumables, software, and accessories to Academic customers to support discovery, translational, and clinical research programs. This role involves supporting Academic accounts and customers in sales activities across the Northeast territory. Our ideal candidate will have a solid technical foundation with knowledge of immunohistochemistry (IHC), immunofluorescence (IF), in-situ hybridization, spatial biology and other tissue biomarker analysis applications, an excellent business acumen, a strong experience building and managing complex sales pipeline, and managing customer accounts. We are looking for a hard-working, determined individual with an entrepreneurial spirit, and passionate about taking Lunaphore's technology to the next level. Key Responsibilities: Achieve assigned territory sales quotas Develop and execute regional, territory, and account-specific sales strategies Drive capital equipment sales cycle from initial engagement to closing Build long-term relationships with customers to drive sales objectives and exceed targets Engage with and qualify new leads to generate new sales opportunities Attend conferences, events, and seminars and present key products and applications Develop a strong technical knowledge of Lunaphore product portfolio and the corresponding spatial biology landscape, and be able to deliver meaningful presentations and insights to scientists working across a wide range of applications, and research stages Work closely with cross-functional teams (Sales, Support, Marketing…) to provide world-class customer satisfaction Identify and share relevant market feedback Maintain an accurate sales forecast, track, and report sales activities in CRM This position includes frequent traveling to customer sites and conferences (50%) and occasional traveling to company headquarters Qualifications: Ideal candidate will have experience selling relevant high value capital equipment Bachelor's degree (or advanced) in a life science related field, or other relevant background allowing you to understand the product's applications easily 3+ years experience in selling high-end life sciences research platforms Experience selling to academia segments, across a wide range of applications including immuno-oncology/neurosciences/immunology Previous experience in Spatial Biology industry is a strong plus Knowledge of in-situ techniques including immunohistochemistry, immunofluorescence, in-situ hybridization, spatial transcriptomics, and similar tissue-based assays is a strong plus Strong communication and presentation skills Entrepreneurial mindset, resilience, long-term vision Autonomous, proactive, and results-driven team player Proficient in English. A clean full driving license is a strong plus Additional Information In addition to base salary, this position is eligible to receive a commission plan and long-term incentive package of stock grants based on individual and company performance, in accordance with company policy A dynamic company where you can have a real impact An environment where you will be able to grow both professionally and personally Collaborate every day with a young, interactive, and motivated team A diverse and international working environment Why Join Bio-Techne: We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA. We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more. We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an E-Verify Employer in the United States. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.$95.9k-157.7k yearly Auto-Apply 13d agoGCP 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 53d agoResearch Application Support Analyst
Dartmouth Health
Remote job
Supports technical aspects of implementing, maintaining, and evaluating Research Applications within the Office of Research Operations (ORO). This role is responsible for application support, issue resolution, end-user support, and data analysis to ensure data quality. The Research Operations Advanced Application Support Analyst will support all efforts and facilitate cross-functional collaboration of the Research Applications within the Research Operations portfolio Responsibilities * Serves as part of a team to act as the system administrator/point of contact in support of the management and administration of the Huron Research Suite (HRS) modules (eIRB, Grants), Advarra eRegulatory (eReg) System, Advarra Electronic Data Capture (EDC) applications, and other research administration systems, as needed. System Responsibilities * Monitor and support integrations between research administration systems, including setting up and maintaining application data exchange. * Participate in system upgrades and modifications, including identifying requirements, configuration, testing, and deployment. * Develops, modifies, and tests user roles, designs access rights, and configures applications for use by users. * Oversees administrative aspects of the applications, such as adding new user roles, new data sets, etc. * Provides support and is the technical resource for complex issues escalated to teammates and/or product vendor(s). * Coordinates with the application vendors on system configuration and support questions. * Participate in vendor meetings, capture and synthesize key outcomes, and communicate relevant updates and action items to the Product Owner * Ensures 21 CFR 11 compliance with applicable systems, including coordinating the evaluation of upgrades on the test environment and leading the validation team to assess risk and follow change control procedures. Maintains and follows all system standard operating procedures, ensuring the system remains validated. Leads system audits and non-conformance reviews per standard operating procedures. Data Reporting and Other Data Needs * Collaborates with ORO offices to develop and manage reports and participate in integrations as needed for new or updated applications. * Maintains administrative tracking documentation (change log/test plans/training and end-user support document inventory). * Examines complex data to optimize the efficiency and quality of collected data and resolves data quality problems. * Reviews reporting requests and analyzes the business requirements to determine custom report development. * Collaborates with external and internal stakeholders on the organization’s application and reporting requirements for research administration while eyeing continuous process improvement, efficiency, and optimization. Outreach and Education * Collaborates with cross-functional teams to improve institutional workflows and provide system support. * Hosts routine meetings with the vendor’s support team(s) as needed. * Assists the ORO offices with reviewing all training and education materials for final review before release. * Lead or facilitate training for end users, including revising vendor training and other outreach materials; lead or facilitate form build and training for end-users;. Performs other duties as required or assigned. Qualifications * Bachelor’s degree with 3 years of system support experience, or the equivalent. * Must have strong computer skills. * SQL skills preferred. * Prior experience with clinical research administration systems preferred. * Must be self-directed, flexible, and have excellent organizational skills. * Excellent written and verbal interpersonal communication skills required. * Must have an analytical approach to problem solving and needs definition. * Remote work experience preferred, but not required. Required Licensure/Certifications - None * Remote:Fully Remote * Area of Interest:Professional/Management * Pay Range:$62,296.00/Yr. - $96,553.60/Yr. (Based on 40 hours per week, otherwise pro rata) * FTE/Hours per pay period:1.00 - 1.00 - 40 hrs/week * Shift:Day * Job ID:35693 Dartmouth Health offers a total compensation package that includes a comprehensive selection of benefits. Our Core Benefits include medical, dental, vision and life insurance, short and long term disability, paid time off, and retirement plans. Click here for information on these benefits and more:Benefits | DHMC and Clinics Careers Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dartmouth Hitchcock Medical Center and Dartmouth Hitchcock Clinics comply with applicable Federal civil rights laws and do not discriminate on the basis of race, color, national origin, age, disability, or sex. We do not exclude or treat people differently because of race, color, national origin, age, disability, or sex.$62.3k-96.6k yearly 12d agoField Clinical Specialist - Shockwave Medical - Corpus Christi - 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: Corpus Christi, Texas, United States, Santa Clara, California, United States of America 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. Johnson & Johnson is hiring for a Field Clinical Specialist - Shockwave Medical to join our team located in Corpus Christi, Texas. 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. 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. Requirements 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. 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 & 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 contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is : Base $100,000 + variable compensation Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************$100k yearly Auto-Apply 60d+ agoLocal Trial Management Base - Immunology - Home Based (US)
Icon Plc
Remote job
Local Trial Manager - Immunology - Home Based (US) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing: The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. The L-LTM will serve as the country-level single point of contact on the study for internal partners. While the L-LTM may delegate tasks to other LTMs or roles on the study, the L-LTM remains accountable for successful completion of those tasks. The L-LTM will manage and oversee the following throughout the study: * Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable. * Execution of local milestones from feasibility through study close out. * Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM). * Inspection Readiness and AQR at the country level. * Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary. * Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence. * Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables. * Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership. What you need to have * BA/BS degree. * Degree in a health or science related field. * 2 years of local trial management or mutually agreed clinical trial experience. * Start-up & Database Locks/Cleaning experience preferred * Immunology experience required * LTM experience in LUPUS/GI preferred * Specific therapeutic area experience may be required depending on the position. * Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures. * Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs. * Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate * To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply$64k-103k yearly est. 4d agoPharma Physician Development Program (Associate Medical Director)
Astellas Pharma
Remote job
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. **Responsibilities and Accountabilities:** Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: 1. **Clinical Development (12 months)** + Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. + Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. + Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. + Support clinical and program risk assessment and mitigation planning + Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. 1. **Medical Affairs (6 months)** + Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. + Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). + Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. + Embed agile ways of working while fostering collaboration across commercial and Medical teams. 1. **Pharmacovigilance (6 months)** + Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. + Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. + Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. + Collaborate with teams on inspection readiness, QMS reviews and CAPAs. + Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. **Throughout the Program** + Participants will benefit from additional developmental opportunities, including: + Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. + Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. + Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. + Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. **Why Join the Program?** This program offers: + Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. + Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. + Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. + Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation. **Qualifications:** **Required** + Medical degree (MD or equivalent). + Clinical: 2 to 5 years of clinical experience, (including clinical fellowships and/or experience as an attending physician in clinical practice) preferably in oncology. + Scientific Research: Prior experience and interest in scientific (non-clinical or clinical) research would be an asset. + No pharmaceutical experience required **Key Skills:** + Strategic thinking, strong analytical, and problem-solving capabilities. + Excellent verbal and written communication skills, particularly in conveying scientific and clinical concepts to diverse global audiences. + Proven ability to work independently with a results-driven approach, as well as collaboratively within teams. + Professional fluency in English. + Highest level of scientific integrity and impeccable work ethic ( + Demonstrate Astellas Core Values: Commitment to Innovation, Integrity, and Impact. **Preferred:** + Published clinical or nonclinical research **Salary Range** $193,200 - $276,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Oncology Development Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans$73k-119k yearly est. 12d agoClinical Associate Project Manager
Trial Library
Remote job
Our mission is to improve health equity by expanding access to cancer precision medicine. About Trial LibraryTrial Library, Inc. is a venture-backed startup founded in 2022 focused on accelerating enrollment and retention to clinical trials with an AI-platform. Trial Library is a mission-driven health technology company dedicated to improving health equity in cancer care by expanding access to precision medicine through clinical trials. We work with community oncology sites, patients, and industry partners to ensure that clinical research is accessible, navigable, and inclusive. As a Clinical Associate Project Manager, you will work closely with the Chief Executive Officer, Chief Product Officer, Director of Operations, Provider Customer Success Manager, and Ally Navigation team to support Study Sponsors on the Trial Library Platform. This is a remote position. You will play a pivotal role in ensuring seamless communication and satisfaction between Trial Library and sponsor study teams (our customers). You will act as the main point of contact and manage relationships with study teams for activated clinical trials on the Trial Library platform. You will build strong relationships with sponsors with a focus on close collaboration with study teams to deliver timely reports and insights regarding Trial Library services. Your Responsibilities Serve as the primary liaison between Trial Library and pharmaceutical study sponsors, maintaining regular communication channels, provide updates, and gather feedback Ownership of all sponsor study team inquiries and troubleshooting to support study teams when necessary Deliver timely reports and insights regarding Trial Library platform's services and performance for contracted clinical trials to sponsor study teams Bridge the gap between Trial Library operations, provider customer success, and pharmaceutical sponsor reporting Oversee outgoing clinical trial related materials to study teams regarding Trial Library performance and services Oversee and deliver post-sales sponsor presentations from launch of services for a trial to ongoing performance reporting meetings Communicate Sponsor feedback to internal stakeholders to implement changes to Trial Library software such as updates to inclusion/exclusion criteria or clinical trial site locations Demonstrate rigor in being detail oriented in reporting obligations to study teams Develop standardized pharma reporting procedures and best practices Oversee all written documentation sent regarding performance metrics to study teams Maintain up to date knowledge of Trial Library product offering for study teams Your Qualifications Excellent organizational and time management skills Excellent communication skills, oral and written Detail and process oriented Minimum 5+ years of professional experience in oncology clinical research Interact with internal and external customers with a high degree of professionalism Experience with oncology clinical trials, pharmaceutical sponsor reporting needs, and trial enrollment activities Demonstrate a bias towards action and seek to intervene before issues arise Strong communicator and persistent, able to influence behaviors to help drive the desired outcomes Facilitate an analytical approach and use data to drive actions Agile and willing to adapt quickly in order to achieve desired outcomes Demonstrated ability to exercise autonomy in engagement of sponsors Our Core Values 1. Ally is our favorite moniker2. The most inclusive approach is worth the work3. Celebrate measurable improvements in equity outcomes4. Fearless advocates for belonging5. Incentives matter to stakeholders choosing our products6. Taking initiative is actually giving 7. We are accountable for the experience of patients and providers8. Empathy and humility are the real dynamic duo Trial Library, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations, and ordinances.$74k-146k yearly est. Auto-Apply 60d+ agoResearch Associate / PRA Kipke Lab / Per Diem / Days
Childrens Hospital Los Angeles
Remote job
NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview This is 100% remote position. CHLA requires a primary residence in California prior to start date. Schedule: Per Diem, Days Purpose Statement/Position Summary: The Research Associate will design, conduct, and document research projects; and teach research surgery to medical students, Residents and Fellows. The Research Associate will also be conducting longitudinal research study in final analysis and dissemination phase focused on youths' engagement in the HIV prevention and care continuum in an effort to prevent new HIV infections, reduce transmission, and reduce HIV/AIDS-related disparities. Minimum Qualifications/Work Experience: 1+ years of experience working in a clinical research role preferred. * 2+ years of experience in biostatistical analysis, authorship experience with professional peer reviewed manuscripts, and demonstrated experience collaborating effectively with study teams members at various levels (PI's, Co-I's, data manager, research associates, etc.) preferred. * Advanced experience using Microsoft Office Suite and proficiency in quantitative statistical software (SAS, SPSS, MPlus) preferred. Education/Licensure/Certification: M.D. or Ph.D. required. Pay Scale Information $44.30-$44.30 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. PRA Kipke Lab$52k-73k yearly est. 2d agoSr. Field Clinical Engineer - Shockwave Medical
6947-Shockwave Medical 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: R&D Operations Job Sub Function: Clinical/Medical Operations Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Senior Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote. 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. The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success. Essential Job Functions Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms. Provide clinical and technical support for key study investigators and clinical leaders at assigned sites. Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues. Administrative activities including training to procedures at site level. Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals. Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools. Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals. Partner with assigned physician advisors to create and deliver recruitment strategies. Partner with vendors that support recruitment activities. Other duties as assigned. Requirements · Bachelor's Degree in a scientific field of study or equivalent work experience. · Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital. · Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials. · Thorough knowledge of Good Clinical Practice (GCP) is required. · Ability to attain and maintain hospital credentials. · 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. · Experience with electronic data capture (EDC) systems. · Must have excellent verbal and written communication skills. · High attention to detail and accuracy. · Able to manage multiple project teams with guidance · Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) · Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America. · May be required to lift up to 25 pounds. 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 & 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 contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Scheduling, Research and Development, Study Management The anticipated base pay range for this position is : US $106,250 - $143,750 / Bay Area - $122,400 - $ 165,600 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************$122.4k-165.6k yearly Auto-Apply 46d agoExecutive Director, ExpMED Oncology Targeted Therapy (Remote)
Boehringer Ingelheim
Remote job
This role will serve as the Associate Head of Experimental Medicine for a given TA/Function and has overall medical strategic responsibility for Experimental Medicine Oncology / Early Clinical Development Immunotherapy. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities In collaboration with the Head of ExpMED TA and fellow Associate Heads, exert medical and scientific strategic leadership for the Therapeutic Area, with a focus on assets within his/her area of responsibility. Maintain and spread knowledge of scientific developments, (products, mechanisms, methodologies) competitor strategies and external environment developments within his/her area of responsibility. Ensures alignment regarding scientific platforms, medical communication and publication strategies as well as the Product Maintenance and Optimization strategies for each substance or project under their responsibility as delegated by TA HoEM. Review and approve final Clinical Trial Reports, Clinical Trial Protocols, scientific publications according to established procedures as delegated by the TA HoEM. Ensures the review of the Master Plans, related Clinical Development plans and Clinical Trial Protocols and programmes, by the CEG for each substance or project under their responsibility as delegated by TA HoEM. Key decision maker in internal committee discussions Serve as a member of the Therapeutic Area Licensing Advisory team, responsible for preliminary, clinical evaluation of in-licensing opportunities and oversight of in-depth in-licensing evaluations as delegated by the TA HoEM. Manage employees belonging to his/her team and establish and maintain adequate standards of people management e.g. Training and personal development, communication, interface definition and processes. Advise, coach and develop his/her teams regarding the preparation of key deliverables within his/her area of responsibility. Support annual international medical budgeting process as delegated by the TA HoEM. Supports and backs TA HoEM according to individually documented delegation of responsibilities. Requirements MD or PhD from an accredited institution. Sound clinical and scientific experience in Oncology/Early Clinical Development Targeted Therapy with ten to fifteen (10-15) years (combination of hospital, academic and industry experience),inclusive of senior leadership role/s; Clinical / pharma experience in the US a plus Strong track record of designing trials that delivered milestones such as PoC (Proof of concept). Expertise in Oncology translational and clinical research with focus on early clinical development (IND enabling activities through Proof of Concept studies), ideally clinical specialization hematology, oncology or organ specialist. Solid relationships with key stakeholders. Sound medical and scientific leadership - maintains team's focus on high priority items even under constantly changing circumstances. Proven success leading global teams preferred. Pragmatic leader that supports and empowers teams to remove hurdles and resolve issues. Ability to act with grace and resilience under pressure. Excellent communication, negotiation and influencing skills. Excellent cross-functional collaboration skills. Full command of English Language. Excellent presentation, training and facilitation skills. Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders. Situational Responsiveness. Deals with Ambiguity. Constantly learns and improves. Advanced Management and Sound Management Skills. Strong leadership skills. Ability to travel globally required Compensation: This position, Executive Director, ExpMed Oncology Targeted Therapy, offers a base salary typically between $250,000.00 and $394,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities$250k-394k yearly 60d+ agoDirector of Strategy & Business Operations - Healthcare & Clinical Research
Paradigm Health
Remote job
Paradigm is rebuilding the clinical research ecosystem by enabling equitable access to trials for all patients. Our platform enhances trial efficiency and reduces the barriers to participation for healthcare providers. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm's seamless infrastructure implemented at healthcare provider organizations, will bring potentially life-saving therapies to patients faster. Our team hails from a broad range of disciplines and is committed to the company's mission to create equitable access to clinical trials for any patient, anywhere. Join us, and bring your expertise, passion, creativity, and drive as we work together to realize this mission. As the Director of Strategy and Business Operations, a member of the Paradigm Strategy Team reporting to the Head of Strategy, your role will be multifaceted and pivotal to the company's success. You will be responsible for driving effective strategic decision making and ensuring operational excellence across functional areas, including product development, commercial, clinical operations, finance, business development, and corporate development. By facilitating structured, data-driven decision-making, effective cross-functional collaboration and execution, and efficient and measurable business processes, you will help shape the growth of our business in the right directions while enabling efficient and scalable execution. Your ability to cultivate and manage strong working relationships with colleagues across functions will be essential for the successful growth of our company. Lastly, your ability to bring a multi-disciplinary skill set-including strategy, operations, project management, and financial analysis/modeling-to bear on a wide range of challenges will be essential to your success in this exciting and challenging role. Our Ideal candidate is someone with 3+ years experience at a top tier consulting firm, where you worked on Healthtech or life sciences (critically, on the consulting/strategy side (not technology implementation or accounting), Plus 2+ years post-consulting at a early/mid stage startup healthtech, in clinical trials or RWD or biopharma SaaS or another loosely related area. What you'll do: Strategy: Lead and support cross-functional workstreams to drive sound, data-driven, and efficient strategic decision-making and execution Bring structured thinking, clear frameworks, and clear, concise communication to strategy work to drive effective decision-making and execution, with strong alignment across executive leadership and functional leaders and teams Support strategy development with data-driven analysis and modeling, including financial models and forecasts Build a deep, data-driven understanding of the overall market (US and ex-US, oncology and non-oncology), the provider landscape, the trial sponsor landscape, the competitive landscape, the landscape of potential partners and acquisition targets, current policy and policy trends, and other areas Infuse data-driven insights and an analytical mindset into strategic decisions while balancing the urgency required to succeed as a startup company Enhance Paradigm's ability to communicate clearly and concisely internally and externally, including with our Board of Directors Business Operations Excellence: Provide effective leadership, facilitation, and project management to drive efficient and effective cross-functional execution of strategic workstreams Design and help implement efficient, measurable operational processes to enable efficient, scalable execution across functions Establish and maintain best practices for project management, quality assurance, and performance metrics Drive continuous improvement efforts to enhance operational efficiency, productivity, and customer satisfaction long-term vision Who you are: BA/BS degree with equivalent work experience preferred 4+ years of strategy and/or business operations experience in healthcare technology or closely related healthcare sectors (clinical research, drug development, clinical trial operations and/or technology, etc.) Strong understanding of the US healthcare system, with deep experience with life sciences companies, health systems, or both Demonstrated ability to learn quickly and to succeed in highly complex, ambiguous, and dynamic environments Demonstrated ability to lead and facilitate, including cross-functional teams, and to drive impact and results with independence and initiative, including with technical teams Demonstrated experience, presence, and credibility with senior executives sufficient to drive decision-making and alignment on challenging, complex strategic questions Excellent quantitative skills, including market sizing, forecasting, and other modeling and analysis Excellent communication skills, including both written and verbal Mission-driven commitment to improving healthcare Mission-driven commitment to diversity, equity, and inclusion The base compensation range is $180,000 - $225,000 USD per year. Actual salaries will vary based on candidates' qualifications, skills, and location. What You'll Receive: Paradigm Health offers a comprehensive Total Rewards package to support your well-being and success, including: Competitive health, dental, and vision insurance Mental health support for you and your family through Spring Health Equity package Unlimited paid time off (PTO) 16 weeks of paid parental leave Flexible work options - remote and hybrid arrangements Company-paid life insurance Company-paid short-term and long-term disability coverage One Medical membership 401(k) plan with company match At Paradigm, we are committed to providing equal employment opportunities to all qualified individuals. We encourage and welcome candidates from all backgrounds and perspectives to apply for our open positions. We are interested in all qualified individuals and ensure that all employment decisions are based on job-related factors such as skills, experience, and qualifications.$180k-225k yearly Auto-Apply 4d agoSoftware Engineer
Character Bio
Remote job
Character Biosciences Character Biosciences is a drug discovery and development company building world-class, deeply-phenotyped databases that integrate genomics with longitudinal clinical and imaging data in age-related macular degeneration (AMD) and glaucoma therapeutic areas. Our interdisciplinary team, comprising experts in clinical science, data science, statistical genetics, machine learning and drug discovery utilize these platforms to determine genetic drivers of disease progression, advance novel therapeutics and define genetics-based patient stratification. Character is currently advancing two programs in AMD towards clinical development with additional programs in earlier stages of discovery research in AMD and glaucoma areas. The Opportunity We are looking for an experienced software engineer to join our team and contribute to the build out of our observational study software and broader data platform. As a member of a small team, you will play an active role in product design and development via partnership with internal end-users at Character Bio. You will play a key role delivering technology solutions that will enable a wide range of functions across the company, including clinical trial operations, data science, and genomics. This role requires a collaborative working style, attentive listening and an ability to translate the expressed needs of non-technical staff, as well as leadership to propose creative solutions that balance tradeoffs. The multi-modality information content within our data can be complex, so candidates should also be literate and interested in longitudinal clinical data, as well as medical image and genomic data, from a scientific and regulatory perspective. This is a fully remote role. Key Responsibilities Collaborate with our clinical research team to develop features that support our longitudinal studies Build appropriate tooling to connect deidentified and processed data with our data science environment Integrate third party software platforms to ingest and transform patient data, and extend these platforms by building and configuring data exploration and analysis apps Skills and Qualifications Bachelor's Degree and 3-5 years of experience building and deploying web applications (familiarity with Django highly preferred) Some familiarity with frontend development (this is not a frontend-heavy role, although there are times when frontend knowledge will be a critical requirement for development). Experience with cloud platforms, CI, and containerized deployments, particularly GCP and Kubernetes Demonstrated ability to communicate technical concepts, gather requirements from, and provide technical guidance to non-technical stakeholders Track record of self-directed work and proactive problem-solving Ability to express a strong product sensibility with user-centered design, and anticipate user needs Comfortable with scoping, designing, and implementing features with minimal technical oversight Preferred Qualifications Experience working with sensitive or regulated data Previous experience in healthcare or clinical research Familiarity with compliance frameworks (HIPAA, 21 CFR Part 11) Compensation & Benefits The annual pay range for this full-time position is $140-180k base + bonus + equity + benefits. The stated compensation range reflects pay for roles based in New York or San Francisco metro area; compensation for hires in other locations may be adjusted based on the local market rate. Benefits include a competitive salary, bonus, strong equity incentives, medical, dental, vision, 401(k), and an accrued paid time off policy. Character is committed to recruiting, developing, and supporting colleagues from all backgrounds. We embrace diversity, equity, and inclusion as an integral part of our culture.$140k-180k yearly Auto-Apply 45d agoSenior Revenue Analyst- REMOTE
Thorne
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: Thorne is seeking a Senior Revenue Analyst to play a critical role in shaping visibility, accuracy, and insight into the company's top-line performance. This individual will lead key components of Thorne's revenue reporting, forecasting, and planning processes, including revenue consolidation, gross-to-net analysis, price/volume/mix decomposition, and channel-level revenue modeling. As a core member of the Strategic Finance team, the Senior Revenue Analyst will ensure revenue trends are accurately captured and translated into actionable forecasts that inform both short-term performance management and long-term planning. This role offers a unique opportunity to deliver high-impact reporting and forecasting that drives a deeper understanding of revenue performance across Thorne's multi-channel business. The position reports to the Senior Director of Strategic Finance and will collaborate closely with Finance and Commercial leaders across the organization. This is a remote position. Responsibilities * Lead the monthly reporting of top-line results, compare performance against plan, forecast, and prior year, and decompose growth drivers including price, volume, mix, and gross-to-net investment * Own the monthly rolling revenue forecast by partnering with channel leaders to gather inputs, translate business drivers into revenue projections and deliver accurate, timely forecasts * Support the annual operating plan by developing channel-level revenue models, translating sales forecasts to unit-level detail, and incorporating gross-to-net and pricing assumptions across all channels * Drive enhancement of reporting tools and analytics infrastructure through automation, data harmonization, and productivity initiatives that improve accuracy, timeliness, and scalability * Design and deliver reporting solutions that elevate analytical insight and user experience, including dashboards, scorecards, and visualizations that simplify complex revenue data * Execute special projects and ad-hoc analyses to support strategic initiatives and evolving business priorities5 * Translate complex financial and operational data into clear, visually compelling presentations for internal and external audiences, enabling data-driven discussions and informed decision-making What You Need * Bachelor's degree in Finance, Accounting or related field required * A minimum of 3 years of experience in Finance or Accounting, preferably in DTC or consumer product environment required. MBA, CPA, CFA, or relevant professional certification is a plus * 2 - 5 years of progressive financial experience, including planning, forecasting, financial analysis and reporting * Strong organization, time management, and interpersonal skills * Passionate, proactive, responsible, resourceful, hard-working, and willingness to learn * Strong analytical and problem-solving skills with the ability to translate and articulate business impact in financial terms * Strong process orientation and personal computer skills, especially in developing financial & analytical models, working with large data sets. Particularly strong excel skills preferred. * Knowledge of visualization tools (e.g. Power BI) to transform financial data and analysis is a plus. * Ability to work independently and as a member of a cross-functional team, and meeting deadlines while managing multiple tasks * Knowledge of Microsoft Navision or Business Central is a plus 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$57k-82k yearly est. 26d agoClinical Practicum Intern (Master's Level)
Charlie Health
Remote job
Why Charlie Health? Millions of people across the country are navigating mental health conditions, substance use disorders, and eating disorders, but too often, they're met with barriers to care. From limited local options and long wait times to treatment that lacks personalization, behavioral healthcare can leave people feeling unseen and unsupported. Charlie Health exists to change that. Our mission is to connect the world to life-saving behavioral health treatment. We deliver personalized, virtual care rooted in connection-between clients and clinicians, care teams, loved ones, and the communities that support them. By focusing on people with complex needs, we're expanding access to meaningful care and driving better outcomes from the comfort of home. As a rapidly growing organization, we're reaching more communities every day and building a team that's redefining what behavioral health treatment can look like. If you're ready to use your skills to drive lasting change and help more people access the care they deserve, we'd love to meet you. About the Role Charlie Health is seeking passionate and driven second-year master's students in mental health programs (such as Social Work, Clinical Mental Health Counseling, Marriage and Family Therapy, or related fields) to join our dynamic virtual care team for their clinical practicum or internship experience. As a clinical practicum student at Charlie Health, you'll gain direct experience working with high-acuity clients in a virtual Intensive Outpatient Program (IOP) setting. Under the close supervision of one of our experienced therapists, you'll develop your clinical skills through a variety of client interactions and treatment modalities. This internship offers a unique opportunity to work across: Group treatment sessions Individual therapy sessions Family therapy sessions Crisis intervention Clinical research Clinical curriculum What You'll Gain Exposure to evidence-based practices used in treating high-acuity teens and adults Experience working within a multidisciplinary team of primary therapists, group facilitators, and care coordinators Training and mentorship from experienced clinicians in the field Skills in virtual care delivery, documentation, and client engagement We're a team of passionate, forward-thinking professionals eager to take on the challenge of the mental health crisis and play a formative role in providing life-saving solutions. If you're inspired by our mission and energized by the opportunity to increase access to mental healthcare and impact millions of lives in a profound way, apply today. Responsibilities Participate in group sessions as well as individual and family therapy sessions under the supervision of an experience clinician Observe and co-facilitate therapeutic interventions using evidence-based modalities Attend clinical supervision meetings and engage in reflective practice to support growth and development Collaborate with members of the interdisciplinary care team to ensure high-quality, coordinated care Maintain confidentiality and adhere to all ethical and professional standards Engage in ongoing learning and training opportunities related to trauma-informed care, telehealth best practices, and working with high-acuity populations #LI-Remote Requirements Enrollment in a master's-level program in Social Work, Clinical Mental Health Counseling, Marriage and Family Therapy, or a related discipline (see list below for examples) Students should be in the second year of their master's program by the time the practicum or internship begins, meeting eligibility requirements to start clinical hours. Interest in working with high-acuity populations and providing trauma-informed care For clinical time, we require a combination of afternoon or evening availability. Non-clinical, administrative, and case management duties can be done outside these hours. A complete schedule will be set individually with the intern to account for clinical time, admin time, and supervision/training meetings. Reliable WIFI connection and familiarity with cloud based communication software (Gmail, Slack, Zoom, Dropbox) Ability to skillfully engage a wide range of ages including children, teens, young adults, and adults over video technology. Strong communication and organizational skills Note: Internship placements are contingent on the availability of clinical supervisors licensed in your state. If you are enrolled in a graduate program we do not currently partner with, additional conversations and a formal agreement with your school will be required before placements are confirmed Example Master's Programs: Master of Science (M.S.) in Mental Health Counseling Master of Social Work (M.S.W.) with a concentration in Mental Health Master of Science (M.S.) in Clinical Mental Health Counseling Master of Arts (M.A.) in Marriage and Family Therapy Other Masters Degree programs that allow pursuit of a Social Work, Marriage & Family, or Counseling license (mental health / therapy focused) Our Values Connection: Care deeply & inspire hope. Congruence: Stay curious & heed the evidence. Commitment: Act with urgency & don't give up. Please do not call our public clinical admissions line in regard to this or any other job posting. Please be cautious of potential recruitment fraud. If you are interested in exploring opportunities at Charlie Health, please go directly to our Careers Page: ******************************************************* Charlie Health will never ask you to pay a fee or download software as part of the interview process with our company. In addition, Charlie Health will not ask for your personal banking information until you have signed an offer of employment and completed onboarding paperwork that is provided by our People Operations team. All communications with Charlie Health Talent and People Operations professionals will only be sent *********************** email addresses. Legitimate emails will never originate from gmail.com, yahoo.com, or other commercial email services. Recruiting agencies, please do not submit unsolicited referrals for this or any open role. We have a roster of agencies with whom we partner, and we will not pay any fee associated with unsolicited referrals. At Charlie Health, we value being an Equal Opportunity Employer. We strive to cultivate an environment where individuals can be their authentic selves. Being an Equal Opportunity Employer means every member of our team feels as though they are supported and belong. We value diverse perspectives to help us provide essential mental health and substance use disorder treatments to all young people. Charlie Health applicants are assessed solely on their qualifications for the role, without regard to disability or need for accommodation. By submitting your application, you agree to receive SMS messages from Charlie Health regarding your application. Message and data rates may apply. Message frequency varies. You can reply STOP to opt out at any time. For help, reply HELP.$29k-43k yearly est. Auto-Apply 33d agoInternship Opportunities - Summer 2026 - Children and Family Law Division - Statewide
Committee for Public Counsel Services
Remote job
The Children and Family Law Division (CAFL) of CPCS is seeking applicants for Summer 2026 internship positions across the Commonwealth. We are interested in law students (both with and without SJC Rule 3:03 Certification), graduate students, and undergraduate students for opportunities with the Children and Family Law Division. We fight for equal justice and human dignity by supporting our clients in achieving their legal and life goals. We zealously advocate for the rights of individuals and promote just public policy to protect the rights of all. Our Values Courage • Accountability • Respect • Excellence We stand with our Clients and the Community in the fight for Justice. We are dedicated to providing zealous advocacy, community-oriented defense and protection of fundamental constitutional and human rights. Our staff across the Commonwealth embodies a diverse group of people from different backgrounds, experiences, abilities, and perspectives. It is through these differences in age, ethnicity, geographic origin, race, faith, religion, and progressive values, that we are able to best serve our clients. Through our internship program we seek to hire, develop, and hopefully retain talented people from all backgrounds. We strongly encourage individuals from non-traditional backgrounds, historically marginalized, or underrepresented groups to apply. The clients we represent are diverse across every context imaginable and bring many unique cultural dimensions to the matters we address. This reality creates a critical need for CPCS attorneys to be culturally competent and able to work well with people of different races, ethnicities, genders and/or sexual orientation identities, abilities, and limited English proficiency, among other protected characteristics. DIVERSITY AND INCLUSION MISSION STATEMENT CPCS is committed to protecting the fundamental constitutional and human rights of our assigned clients through zealous advocacy, community-oriented defense, and the fullness of excellent legal representation. We are dedicated to building and maintaining strong professional relationships, while striving to accept, listen to and respect the diverse circumstances of each client, as we dedicate ourselves to meeting their individual needs. It is our CPCS mission to achieve these goals, and in furtherance thereof, we embrace and endorse diversity, equity and inclusion as our core values as we maintain a steadfast commitment to: (1) Ensure that CPCS management and staff members represent a broad range of human differences and experience; (2) Provide a work climate that is respectful and supports success; and (3) Promote the dignity and well-being of all staff members. CPCS leadership is responsible for ensuring equity, diversity, and inclusion. The ability to achieve these goals with any level of certainty is ultimately the responsibility each member of the CPCS community. AGENCY OVERVIEW The Committee for Public Counsel Services (CPCS) is the state agency in Massachusetts responsible for providing an attorney when the state or federal constitution or a state statute requires the appointment of an attorney for a person who cannot afford to retain one. The agency provides representation in criminal, delinquency, youthful offender, child welfare, guardianship, mental health, sexually dangerous person, and sex offender registry cases, as well as in appeals and post-conviction and post-judgment proceedings related to those matters. CHILDREN AND FAMILY LAW DIVISION OVERVIEW Children & Family Law Division Interns will assist lawyers and work closely with social workers to represent children and parents in cases in which the Department of Children and Families (DCF) removes children from their homes because of claims of neglect or abuse. This unit also provides lawyers to children and parents in child requiring assistance (CRA) cases. Interns will have significant client contact through client interviews and home/placement visits, assist in case investigations, serviced advocacy on behalf of clients, negotiations with opposing counsel, legal research and writing for motion arguments, custody hearings, and termination parental rights trials, review of pre-trial discovery and DCF case files, attendance in education-related matters (suspension and IEP hearings), and appearances in Juvenile Court on behalf of CRA clients. Children & Family Law Division (CAFL) Private Counsel Appellate Panel Unit Interns will assist lawyers representing indigent parents and children in child welfare/family regulation appellate matters. Lawyers in this unit are also available to advise CAFL staff attorneys on appellate issues that arise in trial matters. Interns will have the opportunity to assist with trainings, conduct clinical research and writing, and strategize with attorneys about appellate issues. Children and Family (CAFL) Appeals Unit Interns will assist lawyers representing indigent parents and children in child welfare/family regulation appellate matters. Lawyers in this unit are also available to advise CAFL staff attorneys on appellate issues that arise in trial matters. Interns will have the opportunity to assist with trainings, conduct clinical research and writing, and strategize with attorneys about appellate issues. Children and Family (CAFL) Family Justice Advocates (FJA) - Conflicts Office Interns will assist lawyers and work closely with social workers to represent children and parents in cases in which the Department of Children and Families (DCF) removes children from their homes because of claims of neglect or abuse. This unit also provides lawyers to children and parents in child requiring assistance (CRA) cases. Interns will have significant client contact through client interviews and home/placement visits, assist in case investigations, serviced advocacy on behalf of clients, negotiations with opposing counsel, legal research and writing for motion arguments, custody hearings, and termination parental rights trials, review of pre-trial discovery and DCF case files, attendance in education-related matters (suspension and IEP hearings), and appearances in Juvenile Court on behalf of CRA clients. Qualifications MINIMUM ENTRANCE REQUIREMENTS Interested candidates should have a demonstrated commitment to the principle of zealous advocacy, community-oriented defense, and the protection of fundamental constitutional and human rights. Candidates must also: * Have access to reliable transportation in order to travel to courts, clients, and investigation locations that are not easily accessible by public transportation; and, * Have access to a personal computer with home internet access sufficient to work remotely; APPLICATION INFORMATION Interested applicants should submit (1) Resume, (2) Personal Mission Statement (no more than two pages detailing your interest in the internship, your personal qualities and background, and what draws you to this work, and (3) Writing Sample. Applicants should specify preferred office locations for the Summer 2026 Internship Program. Applications received prior to January 10, 2026 will be given preference. INTERNSHIP FUNDING OPPORTUNITIES CPCS has a limited number of paid internship opportunities for Summer 2026. In order to be considered, applicants may complete the following application: ***************************************************************** For students who are not selected for a paid internship, CPCS can work with students to support the receipt of externship credit or outside funding. Responsibilities OVERVIEW OF REGIONS AND CAFL OFFICE LOCATIONS SOUTHEAST REGION The Southeast Region is home to an ethnically, racially, and linguistically diverse population of immigrants dating back to the 19th century whaling industry. Brockton known as the "City of Champions" because it was home to former undefeated heavyweight boxing champion, Rocky Marciano, and middleweight boxing champion Marvin Hagler. Fall River was once the leading textile manufacturer center in the country and maintains the world's largest collection of World War II naval vessels at Battleship Cove. New Bedford is home to the Whaling National Historic Park. Hyannis is known as the gateway to esteemed Cape Cod and is home to the iconic Kennedy family compound. The area offers beautiful sand beaches, numerous state parks, and quaint towns with picturesque harbors. The Southeast Region of CPCS includes Children and Family Law Division office locations in Brockton, Hyannis, and Fall River. NORTHEAST REGION The Northeast Region is filled with history. Lowell is known as the birthplace of the American Industrial Revolution for its textile manufacturing with many of these historic manufacturing sites preserved by the National Park Service. During the Cambodian genocide, the city took in an influx of refugees, leading to Lowell having the second largest Cambodian-American population in the country. Salem is one of the most significant seaports in early American history and it is well-known for its role as the location of the Salem Witch Trials. The Northeast Region of CPCS includes Children and Family Law Division office locations in Lowell and Salem. WEST REGION The West Region has a diverse topography from the Berkshire Mountains to the banks of the Connecticut River. The region is home to 22 colleges/universities which is the 2nd highest concentration of higher learning institutions aside from the Boston Metropolitan area. The area has long been patronized by artists and is recognized for the Eric Carle Museum, Tanglewood, and Norman Rockwell Museum. The area is famous for all of its "first innovations" including basketball, volleyball, American gas-powered automobile, motorcycle company, commercial radio station, use of integrated parts in manufacturing, railroad sleep car, and the American dictionary. The city of Worcester became a center for the American Revolution that was recognized for his industry and as a result attracted many immigrants of European descent. The city of Springfield was designated by George Washington for an Armory that became the site of Shay's Rebellion and is now a national park and site to the world's largest collection of historic American firearms. The city played a pivotal role in the Civil War as a stop for the Underground Railroad. The West Region of CPCS includes Children and Family Law Division office locations in Worcester, Pittsfield, Springfield, and Northampton. Children and Family Law Appeals office location in Worcester. Family Justice Advocates (FJA) office locations in Worcester and Springfield. CENTRAL REGION The Central Region is famous for its rich history. Boston is not only the capital of the Commonwealth but one of the oldest municipalities in the United States and the scene of several significant events in the American Revolution, such as the Boston Massacre, the Boston Tea Party, Battle of Bunker Hill, and the Siege of Boston. It was a port and manufacturing hub and a center of education and culture, as well as home to the first public park, public school, and subway system in the United States. The area is home to professional sports teams, including Boston Bruins, Boston Celtics, and the Boston Red Sox. The city of Roxbury is known to serve as the "heart of black culture in Boston" and is home to an extremely diverse population. The Central Region of CPCS includes Children and Family Law Division office locations in Boston. EEO Statement The Committee for Public Counsel Services (CPCS) is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, ethnicity, sex, disability, religion, age, veteran or military status, genetic information, gender identity, or sexual orientation as required by Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act of 1990, and other applicable federal and state statutes and organizational policies. Applicants who have questions about equal employment opportunity or who need reasonable accommodations can contact the Chief Human Resources Officer, Sandra DeBow-Huang at ************************$50k-68k yearly est. Auto-Apply 60d+ agoFSP Document Review Specialist II (North America)
Invitrogen Holdings
Remote job
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Summarized Purpose: We are excited to be expanding our Medical Writing Functional Service Partnership (FSP) Team in North America. We are seeking an experienced and skilled Document Review Specialist II who will be dedicated to one or more clients in the FSP space to join our team; experience working in a range of document management systems would be preferred. As a remote-based Document Review Specialist within the FSP Team, you will effectively review regulatory documents, including but not limited to submissions documents, protocols and amendments, clinical study reports, investigator's brochures, and patient safety narratives, to ensure quality standards and adherence to templates, client guidelines, editorial style guides, and industry standards. You will collaborate with internal clients, supporting and enabling effective communication that results in operational excellence and quality deliverables. This role requires meticulous attention to detail, a high English proficiency with the ability to communicate clearly and concisely, and a solid understanding of regulatory document content. Key Responsibilities: Reviews highly technical scientific documents of all types developed within or outside of the company to ensure quality standards that meet or exceed client expectations. Verifies scientific logic and clarity of the document by verifying data in tables, listings, and figures against source documents, checking for consistency according to current regulatory standards and guidelines. Edits for accuracy, consistency, and grammatical correctness. Adjusts schedule to accommodate unexpected requests for priority review. Revises scientific language for usage, flow, clarity, and audience appropriateness. Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment. Maintains, communicates, and applies knowledge of current guidelines, templates, and industry standards. Education and Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification required. Previous editorial experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years'). Experience working in the pharmaceutical/CRO industry preferred. If CRO experience: experience working in a client-dedicated role or with 1 to 2 clients over multiple projects is preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related editorial experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities: Capable of focusing on document details and the overall objectives and intent of document messaging. Good knowledge of the methods, techniques, and procedures of medical writing tasks. Strong analytical ability. Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirements of the FDA and other international regulatory agencies. Attentive to detail and quality of documents, thorough and methodical. Proficient oral and written communication and grammatical skills. Good organizational and planning skills. Good interpersonal skills. Proven ability to work effectively in a team environment. Advanced computer literacy and expertise. Good knowledge and understanding of document management systems. Capable of working well under pressure and remaining motivated. Capable of working both independently and collaboratively with a team in a cross‑cultural, geographically dispersed environment. What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Compensation and Benefits The salary range estimated for this position based in Massachusetts is $69,000.00-$115,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************$30k-49k yearly est. Auto-Apply 7d agoProduct Owner
Eclinical Solutions
Remote job
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. You will make an impact: At eClinical Solutions, our goal is to empower life sciences organizations around the world to manage and analyze clinical data more efficiently through an AI-first approach. We are looking for a Product Owner who will play a key role in translating customer and business needs into actionable user stories that guide the development of the elluminate platform. You will be a champion of user value and data-driven design, working closely with product managers, engineers, UX designers, and clinical domain experts to shape high-impact product features. This role is ideal for someone who is detail-oriented, passionate about user experience, and thrives in a collaborative, fast-paced agile environment. Your day to day: Translate Strategy into Execution Partner with product managers and stakeholders to break down high-level product strategies into clear, detailed epics and user stories Serve as the voice of the customer in agile ceremonies, ensuring the team is always aligned on delivering business and user value Support creation of wireframes and prototypes to visualize workflows and improve user experience Collaborate with engineering and UX teams to refine requirements, review prototypes, and validate deliverables throughout the sprint cycle Facilitate Agile Collaboration Participate in all agile rituals, including sprint planning, backlog grooming, reviews, and daily standups Maintain a well-prioritized product backlog, ensuring clarity, consistency, and alignment with roadmap goals Collaborate cross-functionally with QA, documentation, services, and support teams to ensure successful product releases Contribute to Market & Domain Intelligence Research and document industry trends, competitive offerings, and evolving customer needs Stay informed on clinical trial standards, data workflows, and regulatory requirements Contribute to knowledge sharing across the organization through release notes, internal trainings, and support materials Education & Experience Bachelor's degree in a life sciences discipline, computer science, or related field, or equivalent work experience preferred 5+ years of experience in a product owner, business analyst, or clinical data role within life sciences technology or clinical trials preferred Hands-on experience with agile product development processes and tools (e.g., Jira, Confluence, ProductBoard) Prior experience working on a cloud-based SaaS platform strongly preferred Professional Skills Strong understanding of product development lifecycle and user-centered design principles Proven ability to write clear, concise user stories and acceptance criteria Excellent communication and interpersonal skills; comfortable presenting ideas and facilitating cross-team discussions Highly organized with strong attention to detail and the ability to manage multiple priorities Curious, analytical mindset with a passion for solving real-world problems in clinical research Technical & Domain Skills Familiarity with clinical trial workflows, EDC systems, and regulatory standards (e.g., CDISC, 21 CFR Part 11, IHC E6) is a plus Experience creating or reviewing clinical metadata and working with data visualization tools is desirable Working knowledge of agile methodologies and best practices for backlog management Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. #LI-AB1 Pay Range US Pay Ranges $100,000-$120,000 USD$100k-120k yearly Auto-Apply 34d agoEDC Developer / Programmer
Celerion
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 support a business creating life-saving treatments? If so, we can't wait to meet you! We are looking for a performance-oriented, innovative and self-motivated team player to join our Clinical Data Sciences team as a full-time Electronic Data Capture (EDC) Database Developer / Clinical Programmer. You will be responsible for administration of EDC Database including evaluation, analysis, design and/ or recommendations to achieve goals and excellent results in a fast-paced, ever-changing environment. This is a full time, remote opportunity, but may travel for training and key meetings. As an EDC Database Developer, you will build and administer EDC trials for client contracted projects including protocol/requirements evaluation, electronic case report form (eCRF) design and build with corresponding edits. This role will have technical interaction with vendors that are supporting the applications and troubleshoot/ escalate problems on systems to appropriate partners. This role will provide expert guidance to the design, development, validation, implementation and maintenance of study set-up. Additionally, this role will manage the deployment of EDC trials and set up interface connections between EDC and other systems. In this role you will: Serve as a subject matter expert in Veeva Clinical Data Management Suite (CDMS), including Veeva Electronic Data Capture (EDC) and Veeva Clinical Database (CDB) Perform all activities related to eCRF design and EDC build programming for assigned projects Perform EDC edit check programming for assigned projects based on edit check specifications for both simple and complex edit checks Create test data to verify both screen design and edit check programming prior to deploying to User Acceptance Testing (UAT) Set up test environments and coordinate project team members for execution of test scripts Program and configure listings and reports using clinical reporting tools such as Veeva Clinical Database (CDB) Ensure secure and high-integrity database imports from vendor transfers using Celerion data transfer standards Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution. Maintain global clinical trial database standards (CDISC) Requirements: Bachelor's degree in a related field preferred 3 years of clinical data management experience Ability to program using SQL required Experience with EDC systems (i.e. Veeva CDMS, Medidata RAVE, etc.) Experience with Veeva EDC and Veeva CDB preferred Proficient computer skills with understanding of clinical systems and data administration Must be organized, an effective written and oral communicator Must have the ability to multi-task, within a fast-paced environment, and build strong relationships #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.$68k-91k yearly est. Auto-Apply 54d ago
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