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The National Director, Rare Disease is a senior leadership position accountable for setting the US strategy, operational oversight, and performance management of the Rare Disease Field Medical Affairs (FMA) team. This role manages the unique challenge of strategically deploying a small MSL team across a disparate rare disease presence (including PKU and ALS), ensuring effective scientific exchange, supporting identification for evidence generation needs, and collaboration with patient advocacy and policy teams to ensure strategy reflects patient perspectives. The Director is responsible for medical customer engagement, including the hiring, development, coaching, and strategic deployment of the Rare Disease MSLs (including the PKU and ALS MSLs). This position reports directly to the Rare Disease Medical Business Unit Lead. **** **Key Responsibilities:** **Leadership and People Management** + Oversee the recruitment, on-boarding, training, and performance management processes, including development of performance metrics, for the Rare Disease FMA team, ensuring all personnel meet high professional and scientific standards + Lead, mentor, coach, and support performance management of the national team of Rare Disease MSLs, fostering a culture of scientific excellence, accountability, and patient focus + Manage the US FMA budget, resource allocation, and key operational metrics to optimize field effectiveness and efficiency + Represent stakeholder needs, insights, and knowledge to other parts of Otsuka including senior leadership and other internal partners **Strategic Deployment and Stakeholder Engagement** + Develop and implement the overarching US FMA strategy and annual operating plan, focusing on strategically deploying MSLs to cover a disparate rare disease presence and small patient populations + Direct the team's efforts to identify centers and/or patients suitable for evidence generation (e.g., registries), recognizing the significant recruitment challenges inherent in rare diseases + Ensure MSLs effectively interact with multidisciplinary care teams of specialists (e.g., metabolic specialists for PKU, neuromuscular specialists for ALS) to foster comprehensive scientific exchange + Lead the strategy for connecting with key external stakeholders, including patient advocacy groups at national and international congresses, ensuring coordinated scientific coverage and efficient resource use + Maintain relationships with key opinion leaders, healthcare professionals, and key accounts to facilitate scientific exchange, and will act as the primary point of contact for these external stakeholders. **Operational Excellence** + Maintain accountability for ensuring all field activities, scientific exchanges, and documentation adhere to relevant company SOPs, regulatory requirements, and industry guidelines + Monitor key performance indicators (KPIs) and operational metrics for the national team, using data to drive continuous improvement in scientific and medical customer engagement, efficiency, and insight collection + Oversee the consistent capture, aggregation, and synthesis of high-quality medical insights from the field to inform internal strategic decision-making within Medical Affairs and across the broader R&D organization + Consider technology and AI to support workflow improvement **Cross-functional Integration** + Serve as the primary field medical affairs representative to the Rare Disease Medical Business Unit Lead and core cross-functional leadership team (e.g., Commercial, Market Access, etc.) + Coordinate with the Clinical Development team to support site identification, feasibility assessments, and operational excellence for clinical trials within the Rare Disease space **Compliance and Training** + Ensure all activities adhere to applicable regulations, compliance, guidelines, and industry standards. + Stay abreast of relevant regulatory and legal developments, providing guidance and training to the team as needed. + Able to fulfill required internal company training requirements in a timely manner **Qualifications** **Education and Experience:** + Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent) + Minimum of 10 years of field experience in the pharmaceutical or biotechnology industry + Minimum of 3-5 years of direct people management experience leading a field-based MSL team (Regional or National responsibility required) + Extensive experience in Rare Disease or a highly specialized therapeutic area with complex patient journeys and limited physician specialists + Proven success in developing and executing national medical strategies, budget management, and clinical trial support **Skills and Competencies:** + Exceptional ability to lead, motivate, and manage a remote, high-performing scientific team + Strong ability to lead, influence, and collaborate in a matrixed environment regardless of reporting structure and operating under ambiguity without a set playbook. + Superior strategic planning and organizational management skills, capable of translating broad strategy into tactical execution plans under constraints of a small team size + Deep understanding of the Rare Disease patient and provider ecosystem, including multidisciplinary care models, patient advocacy, and diagnostic pathways + Excellent communication, presentation, and cross-functional leadership skills, with proven ability to influence + Ability to travel at least 60% - attend regional and international conferences / workshops to obtain new competitive information, keep abreast of clinical trends and support, and maintain relationships with key investigators and scientific research **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities. ** Summary:** The research assistant position is an entry-level, full-time role for professionals who would like to gain clinical research experience. OhioHealth Research Institute (OHRI) is a centralized department that fosters medical treatments and enhanced patient experiences through clinical trials, scholarly activity and other programs. The purpose of this position is to provide coordination and support for OHRI Research Operations as it relates to therapeutic/interventional clinical trials, academic research, regulatory, quality assurance and other research operations roles as needed. This position is responsible for assisting research coordinators, regulatory consultants, research specialists, research activation coordinator and other research personnel (as determined by research leadership) in regard to specific team/project activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Manages complex administrative tasks in support of research administration and clinical trials, including but not limited to screening patients, entering/abstracting data, processing research specimens, maintaining clinical trial inventory and documentation (such as specimen kits, long term storage/archival), document filing, assisting with basic IRB submissions, scheduling and coordinating project meetings and assisting with other core administrative activities in support of research operations. Based on performance and demonstrated competency, OHRI research assistants who do not possess a bachelor's degree may be eligible to apply for a clinical research coordinator, regulatory coordinator or other applicable position within OHRI. **Responsibilities And Duties:** As assigned by manager, the research assistant is responsible with coordinating the following objectives to support OHRI research operations: Supports research staff with execution of high acuity/enrolling clinical trials. This includes but is not limited to data entry, processing and shipping of laboratory samples and activating and closing out research studies. Extracts and records physical findings, laboratory data and other details essential to each study onto required data collection forms/software applications within the designated time period. Assists research staff with reporting adverse events and protocol violations / deviations to the study sponsor and investigator to ensure the health, safety and welfare of the participant. Participate in protocol meetings to review study-related procedures and visit flow. Accurately records and extracts data from source documentation onto required data collection forms (paper or electronic) in a timely manner. Maintains accurate and timely source documentation. After study closeout visits, prepares study documents for archiving. Supports OHRI Regulatory team in maintaining investigator credentials and other supporting documents as needed. Interacts and maintains liaison with colleagues, investigators, staff and outside/community agencies in facilitating department objectives Assists with scheduling site monitor visits for clinical teams as needed. Provides administrative support for shipping logistics, temperature monitoring logs and tracking metrics as needed. Assists in audit preparedness activities for OHRI. Assists with maintaining study records according to sponsor and/or regulations. Assist in the development of reporting metrics. Assists with recording meeting minutes and timely distribution. Attends relevant training courses on policy and compliance. Other administrative duties as assigned. **Minimum Qualifications:** High School or GED (Required) **Additional Job Description:** Field of Interests: Clinical Research, Project Management, Research Administration, Life Sciences, Pharmaceutical sciences, Clinical Laboratory Technology, public health, health policy, health economics, or other health sciences. **SPECIALIZED KNOWLEDGE** Exceptional organization and time management skills. Detail-oriented person with the ability to work independently on multiple tasks. Ability to understand and communicate requirements to others. Excellent verbal, interpersonal and written communication skills. Strong computer skills with high level of proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and database applications. High level of initiative and ownership with the ability to self-motivate. Works well independently and in team settings. **Work Shift:** Day **Scheduled Weekly Hours :** 40 **Department** Heart & Vascular Research Clinical Services Join us! ... if your passion is to work in a caring environment ... if you believe that learning is a life-long process ... if you strive for excellence and want to be among the best in the healthcare industry Equal Employment Opportunity OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment

Ametris is an international leader in the development of validated medical-grade wearable solutions used to measure physical activity, sleep, and behavior patterns in the broader global academic and pharma research communities. Ametris is looking for a Content Strategist who will be responsible for planning, creating, editing, publishing, managing, and optimizing a wide range of scientific content, including social media, email campaigns, and thought leadership materials, ensuring all external messaging and materials are consistent with the company's goals, strategy, and brand voice. This work is crucial for driving brand awareness, engagement, and conversion for Ametris' technology solutions. We are looking for an individual who possesses the ability to think outside the box, who has outstanding character while working within a team environment, possesses excellent communication skills, is a self-starter, has compassion for co-workers and clients alike, and has the ability to maintain a professional attitude and appearance under any circumstance, and able to teach/coach/mentor new team members. We hope you'll consider joining us in our mission to pioneer the digital transformation of clinical research! Requirements The essential duties and responsibilities of this role are to: Develop and execute content marketing strategies to support overall marketing goals and brand objectives. Create high-quality, engaging, and informative scientific-focused content for various digital platforms, ensuring alignment with brand voice and messaging. Collaborate with cross-functional teams, including science, commercial, and product, to gather information and insights for content development. Research and stay updated on industry trends, clinical trial technology, and digital health innovations to enhance content quality. Manage communications calendar, ensuring timely and consistent publication of content across digital channels. Develop and manage our content assets library and lifecycle Monitor content and campaign performance and engagement metrics, and adjust strategies as needed to maximize impact. Edit and proofread content to ensure accuracy, clarity, and adherence to brand guidelines. Perform primary and/or secondary market research Stay current on emerging digital marketing and content creation trends and tools to continuously enhance content quality. Support the planning, promotion, and execution of our annual scientific conference Contribute to the development of marketing campaigns and initiatives by offering creative content ideas and strategies. Required Qualifications College degree in marketing, communications, or related field. At least 5+ years of experience working in marketing, communications, or, related field. Experience using social media in a professional capacity Comfortable with web-based project management tools and virtual collaboration technologies Excellent writing, editing, and proofreading skills with a strong attention to detail. Deep understanding of B2B content marketing framework and best practices. Deep understanding of the B2B marketing-sales funnel and prospecting strategies. Adept at storytelling and creating content that resonates with various audiences. Experience in medical/health technology, life sciences, clinical trial research, and/or academic research industries Proficiency in using marketing automation tools, CMS (Content Management System), and SEO best practices. Familiarity with content creation tools and software, including graphic design tools. Experience with data analytics tools to measure content/campaign performance and other marketing metrics Strong project management skills to handle multiple tasks and deadlines effectively. Ability to work independently and collaborate effectively with cross-functional teams. Passion for improving people's lives through science and technology and staying current on industry trends Preferred Qualifications Experience in medical/health technology, life sciences, clinical trial research, and/or academic research industries preferred Proficiency with digital design and publishing programs (Canva, Adobe Creative Suite, HubSpot CMS) and familiarity with SEO and content optimization is preferred Experience managing digital or social media advertising campaigns preferred Certification in Google Ads, Google Analytics, or HubSpot is a plus Benefits At Ametris, we do our best to offer benefits and a work environment that is positive, fun, and tailored towards the needs and feedback of our team members. We do so by offering: A casual "dress-code" environment A family-oriented and collaborative workplace Paid time off (including paid time off for your birthday) And a very generous suite of benefits including: medical, dental, vision, basic/life accidental, short/long term disability, identity theft, 401K (plus a match), and supplemental insurance options

We are seeking three experienced and highly motivated individuals to join our team for a Clinical Operations Educator position. As Clinical Operations Educator you will be fully dedicated to training and education activities supporting the monitoring roles in clinical operations e.g. Clinical Research Associate (CRAs), Clinical Research Managers (CRMs), in the Global Clinical Trial Operations (GCTO) Regions in alignment with strategic priorities for the Regions, supporting an organization of more than 4000 FTEs. This role focuses on creating role-based, therapeutic area-specific, and process and system training materials and delivering them through live, virtual, or recorded sessions to support GCTO Regions. You will work collaboratively within the Monitoring Excellence team and engage with key stakeholders across GCTO to ensure training curricula are effective, through feedback and performance metrics, relevant, and aligned with business objectives. Main Responsibilities Develop Training Materials: Create and maintain training content aligned with Global Clinical Development standards and Good Clinical Practices (GCPs) and End to End Monitoring activities, including role-based and therapeutic area-specific modules, monitoring processes, and systems. Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. Defines and contributes to the development of training strategies for GCTO Regions Deliver Training Sessions: Conduct and deliver live, face to face, virtual, or recorded Training for GCTO roles as required, ensuring engagement and knowledge retention, including train the trainer sessions as needed. Collaborate Cross-Functionally: Work closely with our Company's R&D Learning & Development, subject matter experts, and process owners to design and implement effective training material. Collaborates with our Company's R&D Learning & Development in the development and implementation of role-based training curricula. Communications Support: Leads and develops communication materials (email, web content, presentations) to support training initiatives and business processes. Monitor Training Effectiveness: Use metrics, surveys, and feedback tools to assess training impact and identify training needs, areas for improvement adjusting plans as appropriate to deliver improved performance. Promote Best Practices: Implement and advocate for best practices in training design and delivery, ensuring alignment with company goals and quality standards. Ensures that training maximizes competency with performance-based metrics tied to quality results. Manages and oversees functional or cross-functional networks of training process owners/subject matter experts. Collaborates with GCTO to increase visibility of local training, ensure alignment, avoid duplicity and globalize local training when applicable. Provides back-up for Clinical Operations Educators in other Regions as needed. Qualifications, Skills & Experience Required Educational Requirements: Bachelor's degree in science (or equivalent e.g. nursing qualification) Preferred Educational Requirements: Advanced degree, (e.g., master's degree, M.D., PhD) Required Experience: 5 years of experience in clinical research, with mandatory 2 years of CRA experience. 6 months of experience delivering training sessions, such as local or country-level training or subject matter expert (SME) training. Preferred Experience: 1 year CRM experience Required Knowledge and skills: Strong knowledge of drug development and clinical trial processes, including relevant standards and documentation. Familiarity with FDA Good Clinical Practices, ICH Guidelines, and other major regulatory agencies' regulations and guidance. Experience working in a hybrid environment with international cultural diversity. Proficiency with learning technologies and platforms for delivering and tracking training. Strong educational and coordination skills with demonstrated success in training delivery. Excellent oral and written communication skills and ability to retain the attention of diverse audiences. Flexibility to work across different time zones to collaborate globally and deliver training sessions as needed. Demonstrated knowledge of how people learn and the ability to use various instructional approaches to enhance learning outcomes. Demonstrated teamwork and leadership skills across organizational levels. Ability to embrace change/improvement. Demonstrated ability to analyse, interpret and solve problems. Extent of Travel: up to 40% Required Skills: Accountability, Accountability, Adaptability, Business Processes, Clinical Data Management, Clinical Development, Clinical Research, Clinical Site Management, Clinical Trial Management Processes, Clinical Trials, Clinical Trials Operations, Communication Management, Cultural Diversity, Decision Making, Drug Development, Good Clinical Practice (GCP), Information Retention, Leadership, Nursing, Quality Management, Quality Standards, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk Based Monitoring {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): No Job Posting End Date: 12/18/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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

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.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio. Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives. Innovation & Execution Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine. Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. Risk Management & Problem Solving Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges. Thought Leadership & External Engagement Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices. Team Leadership & Development Manage and mentor a diverse team of data scientists and people managers across geographies. Foster career growth through open dialogue, performance management, and strategic development planning. Operational Excellence Ensure GxP compliance in data science programming for clinical trials. Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency. Executive Communication Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence. Qualifications Ph.D. in Biostatistics, Bioinformatics, or related computational sciences. Deep expertise in statistical methods and their application in clinical trials. Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics. Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine). Proven experience presenting at external forums and influencing regulatory authorities. Strong people leadership experience in a Data Science setting. Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred. Eisai Salary Transparency Language: The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

At Cogstate, we're advancing the science of brain health - making it faster, easier, and more accurate to assess cognition across clinical trials, healthcare settings, and everyday life. Our digital cognitive assessments are trusted by researchers, clinicians, and pharmaceutical partners around the world, helping to drive breakthroughs in neuroscience and improve outcomes for people living with neurological conditions. Founded on decades of cognitive science and backed by rigorous validation, Cogstate's assessments are used in more than 150 countries and over 2,000 clinical trials. Our global team of experts - spanning psychology, data science, operations, and technology - works together to solve complex challenges in brain health assessment, always with a patient-first mindset. Whether we're supporting a multinational Alzheimer's trial or developing tools to bring cognitive testing into routine care, our work is meaningful, collaborative, and constantly evolving. At Cogstate, we're not just imagining the future of brain health - we're building it. That's why we're seeking a Coordinator, Learning Services accountable for supporting the Learning Services team by efficiently organizing and executing learning content initiatives. Key responsibilities include creating, adding, and revising content within the Learning Management System (LMS), scheduling project meetings and timelines, effectively communicating across portfolio teams, and ensuring the timely delivery of completed training materials. The coordinator also ensures that all team members adhere to the established project schedule. The LMS Administrator is responsible for the effective delivery, communication, and management of e-learning programs, ensuring they align with the organization's training objectives. The ideal candidate for this position should be detail-oriented, capable of multitasking, and comfortable working independently in a dynamic, fast-paced environment. These activities help ensure that projects are executed efficiently and effectively, meeting the organization's goals and objectives Key Responsibilities Training Coordination: Organizing, scheduling, and completing projects for training deliverables and managing training content within the LMS. Course Development and Maintenance: Develop and maintain eLearning courses, ensuring they are up-to-date and meet the organization's standards Technical Support: Provide technical support to users, troubleshoot issues, and ensure the LMS is functioning correctly Content Management: Upload, organize, and manage learning content within the LMS System Optimization: Collaborate with internal teams to identify areas for improvement and suggest modifications to optimize the system Reporting: Generating reports to monitor client training progress and course completion rates. Meeting Coordination: Schedule and organize project meetings. Documentation and Reporting: Manage project-related paperwork such as emails and other forms of communication Risk Management: Identify and raise potential problems and technical issues to the Learning Services Team Quality Control: Ensure that project deliverables meet the required quality standards and specifications Communication: Act as a liaison between the project team and stakeholders, ensuring clear and effective communication. Requirements Bachelor's degree and/or 2+ years of relevant experience. A minimum of 2 years of experience in LMS administration is required. Proficiency in Administering an LMS, specifically Absorb or a similar learning management system, is necessary. Experience in mid to large size corporate LMS required (Absorb, Cornerstone, Workday, Continu, Bridge, Docebo, or similar). Intermediate knowledge of Microsoft 365 is required. Articulate 360 certification is preferred, or candidates should be willing to obtain certification. Previous experience in project management, service-related fields, or administrative support is preferred. Skills, Knowledge and Specialist Expertise Communication Skills: Strong written and verbal communication abilities to interact effectively with users and stakeholders. Organizational Skills: Capable of managing multiple tasks and prioritizing effectively. Technical Proficiency: Skilled in using learning management systems and other educational technologies. Flexibility: Can adapt to changing needs and dynamic environments. Analytical and Problem-Solving Abilities: Able to troubleshoot technical issues and analyze system performance. Eagerness to Learn: Demonstrates a strong desire to learn and actively seeks feedback to adapt to new circumstances. Attention to Detail: Meticulous in problem-solving, ensuring accuracy, procedure adherence and motivated to enhance the educational process. Thrive in Fast-Paced Environments: Possesses strong organizational skills and excels under pressure. Interpersonal Skills: Exhibits excellent interpersonal skills and proven ability to learn quickly, plan effectively, and take initiative. What's In It For You Remote Work Practices: Cogstate is a virtual first company. Cogstate employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom! Generous Paid Time-off: Cogstate employees receive 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays. 401(k) Matching: As you invest in yourself and your future, Cogstate invests in you too: we match up to3% of your yearly salary in Cogstate's 401k program. Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position. Health, Dental & Vision Coverage: We've invested in comprehensive health & dental insurance options with competitive company contributions to help when you need it most. We also offer free vision insurance for all full-time employees. Short-Term & Long Term Disability Life Insurance: 100% employer sponsored Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts Learning & Development Opportunities: Cogstate offers a robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications in applicable areas of interest. Wage Range$55,000-$65,000 USD Our Culture We bring our whole selves to work every day. We're courageous and we deliver together. We're passionate individuals who enjoy working together. We're brave enough and care enough to have the right conversations to get the best outcome and are famous for our can-do attitude. We see challenges as opportunities and move with pace to achieve our goals. If you're ready to help us in our journey to optimize the measurement of brain health around the world, please apply now! Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the company. If you need assistance in applying please email *****************************. Privacy Notice for Job Applicants Cogstate is committed to protecting your personal data. We collect and process your information for recruitment purposes in compliance with applicable laws, including the Australian Privacy Principles (APPs), the UK General Data Protection Regulation (UK GDPR), California Consumer Privacy Act (CCPA), Virginia Consumer Data Protection Act (VCDPA), Colorado Privacy Act (CPA), and similar laws in other jurisdictions. For more information on how we collect, use, and protect your data, and your rights under these laws, you can find Cogstate's privacy policy by clicking here.

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. *********************************************

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.

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: Customer Management Job Sub Function: Technical Customer Service Job Category: Professional All Job Posting Locations: Irvine, California, United States of America Job Description: 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 ******************* Johnson & Johnson is hiring for a Clinical Service Specialist to join our team. The position is FULLY REMOTE and can sit anywhere in the US. JOB SUMMARY: The Clinical Service Specialist provides support on the use of Johnson and Johnson Medical Device products, including, but not limited to, Biosense Webster Inc. and Acclarent. The specialist is responsible for interacting with customers over the phone and occasionally in person and handling customer technical inquiries and complaints. DUTIES & RESPONSIBILITIES: Under limited and following all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position: · Provide expert clinical product and technical assistance to internal and external customers on the use of BWI, Acclarent, and other Johnson and Johnson medical device systems (e.g., the CARTO system and associated software modules/RF generator/catheters; · Accurately input product complaints reported via phone or other channels of communication. · Act as a technical educational consultant to Call Center Customer Support Representatives (CSRs) · Provides guidance to customers, including Field Service Engineers (FSEs), Clinical Account Specialists (CAS), Territory Managers (TMs), doctors, nurses, and hospital biomedical engineers, and assists when customer satisfaction issues arise. · Troubleshoot/diagnose and resolve technical difficulties to avoid delays in customers' patient case procedures. · Support the release of Johnson and Johnson's new products introduced to the market. Will be required to maintain advanced clinical knowledge of cardiac ablation, imaging, and EP. · Mentor and coach Call Center CSRs. · Manage customer expectations regularly before and after interactions to ensure customer satisfaction. · Completes documentation and administrative tasks per policy and procedures promptly. · Log in to the Call Center phone support system and be available for calls during scheduled hours. · Perform field rides along with local field service and commercial teams. · Complete required travel ( · Position requires sitting for extended periods. · Performs other duties assigned as needed. EXPERIENCE AND EDUCATION: · Bachelor's Degree in a STEM-related field or four years of relevant professional work/military experience. · Minimum of 4 years of clinical or technical work experience in a patient care or hospital environment. · Experience working with highly complex technical systems · Electrophysiology/Catheter Lab or EP/Cardiovascular Device Industry experience is strongly preferred. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS : · CEPS (IBHRE), RCES/RCIS certification preferred · Maintain advanced clinical knowledge of cardiac ablation and cardio imaging, technical knowledge of EP technology, advancements, and the business landscape. · Effective communicator at all levels · Problem solver who can think critically in high-pressure environments · Able to take large amounts of data and translate information into actionable insights. 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: Clinical Operations, Clinical Research Trials, Clinical Services, Clinical Support, Clinical Trials Preferred Skills: Accelerating, Applications Support, Business Behavior, Coaching, Customer Centricity, Customer Experience Management, Customer Retentions, Customer-Support, Customer Support Operations, Customer Support Trends, Data Analysis, Issue Escalation, Problem Solving, Product Knowledge, Service Request Management, Teamwork, Technical Troubleshooting The anticipated base pay range for this position is : US : $79,000 - $127,650 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. *********************************************

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: This position is accountable for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). This position is accountable to the Clinical Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution and delivery of assigned trials. This includes vendor selection, implementation and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials. Individuals may serve in regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input. This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables. Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable. Essential Job Responsibilities: Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies. Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally. Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally. Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team Lead feasibility assessment and selection of countries and sites for trial conduct. Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals. Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables. Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable. Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable. Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings. Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct. Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate. Performs other duties as assigned or special projects as needed.

Join Clario and help transform lives by unlocking better evidence. As a Respiratory OverRead Clinical Specialist, you will play a critical role in ensuring the accuracy and quality of pulmonary function data for clinical trials, supporting our mission to bring life-changing therapies to patients faster. What We Offer Competitive compensation Private health insurance Engaging employee programs Flexible work schedules Attractive PTO plan Flex workspace What You'll Be Doing Perform analysis on pulmonary function data Resolve questions from sponsors, investigator sites, monitors, and project managers regarding data quality Ensure all Respiratory OverRead clinical trials meet contracted turnaround times Provide periodic status reports to the Director of Respiratory OverRead Complete other related duties as assigned What We Look For Bachelor's degree in respiratory therapy, physiology, life sciences, or equivalent practical experience Minimum 2 years of experience in pulmonary function testing or related field Preferred certifications: NBRC (CPFT, RPFT, CRT, RRT) or NIOSH Respiratory Surveillance Training Program Strong analytical skills with ability to develop solutions for complex problems Excellent written and verbal communication skills Proficiency in Microsoft Office (Word, Excel, PowerPoint) and G Suite applications Ability to work independently in a dynamic environment At Clario, our purpose is to transform lives by unlocking better evidence. It's a cause that unites and inspires us. It's why we come to work-and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster. Clario is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Who We Are Vial is a hyper-scalable biotech company advancing programs into the clinic by leveraging dramatically cheaper trials and computationally designed therapeutics. Our mission is to reimagine drug development in order to cure all human diseases. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision. Vial is fully remote and was founded by Simon Burns in October 2020. Since our founding, we have grown rapidly to a team of 50+ employees with over $100 million in funding from leading investors including General Catalyst, Box Group, and Byers Capital. Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery. Why You'll Love Working At Vial Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life. Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact. The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together. Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn. What You'll Do Support the Clinical Development team in planning and execution of early-stage clinical trials. You'll gain exposure to protocol development, trial operations, and the systems that keep studies running smoothly. Key Responsibilities * Assist with preparation and review of trial documents (protocols, informed consent forms, study reports) * Track study timelines, milestones, and deliverables * Help organize and maintain clinical trial data, regulatory submissions, and correspondence * Support coordination with sites, CROs, and internal stakeholders * Contribute to process improvement projects within clinical operations What You Will Bring * Strong organizational skills and attention to detail * Interest in clinical research, drug development, or healthcare operations * Ability to manage multiple tasks and prioritize effectively * Strong written and verbal communication skills Preferred Skills * Background in life sciences, public health, or related field * Familiarity with clinical trial design or regulatory environment (FDA, ICH/GCP) * Experience with project management tools (Notion, Excel, or similar) * Previous internship or coursework in clinical research a plus

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds... ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients. The Principal Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions. Key Responsibilities Technical Leadership Lead programming activities for oncology clinical trials across multiple studies. Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines. Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions. Provide SAS programming expertise to support complex data derivations and analyses. Review and ensure traceability, consistency, and quality of all programming deliverables. Project & Study Management Act as programming lead for assigned studies, managing timelines and deliverables. Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs. Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to Kite's programming standards. Support integrated analyses including ISS/ISE. Regulatory & Submission Support Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides. Ensure all programming meets regulatory requirements (FDA, EMA, PMDA). Contribute to responses for regulatory queries and data requests. Required Qualifications Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. 8-12+ years of statistical programming experience in pharma/biotech or CRO. Expert-level proficiency in SAS. Strong understanding of CDISC SDTM and ADaM standards. Significant experience supporting oncology clinical trials (hematologic or solid tumors). Experience supporting regulatory submissions and preparing submission-ready outputs. Excellent communication skills and ability to collaborate cross-functionally. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Principal#Contract

Career CategoryResearchJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, Statistical Innovation (DSI) What you will do Let's do this! Let's change the world. In this vital role you will critical expertise and leadership in the design and planning of innovative development programs and clinical trials. Responsibilities: Guides Product Strategy and Study Design Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP) Reviews key phase 2 and 3 protocols and provides input during the TA TRC review Provides Technical Expertise Provides technical expertise to GSL and EGT on innovative study designs and advanced analytical methods Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs Provides guidance and training to the Simulation and Modeling biostatisticians. Builds Cross-functional Network Develops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA ‘team' approach when interacting with product teams Forms relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process Establishes relationships with TA TRC members to ensure alignment in development strategies Promotes the advancement of innovative designs and analysis methods Builds professional network with external peers in innovative designs and analysis methods Promotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessions What we expect of you We are all different, yet we all use our unique contributions to serve patients. The director we seek has these qualifications. Basic Qualifications: Doctorate degree and 4 years of Biostatistics/Statistical experience Or Master's degree and 8 years of Biostatistics/Statistical experience Or Bachelor's degree and 10 years of Biostatistics/Statistical experience Preferred Qualifications: 10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, implementation, analysis and reporting Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc. Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research Proven experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development Expertise in advanced statistical analysis methods, modeling and simulation Knowledge of multiple disease areas and related regulatory guidelines Experience in leading regulatory and/or reimbursement submissions Strive for innovation and quick adaptation to new industry trends Well recognized statistical and strategic leadership among statisticians and cross-functional teams External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia) Scientific research/publications in one or more areas of statistical science Strong technical and effective communication skills Managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 217,725.00 USD - 246,888.00 USD

PURPOSE AND SCOPE: The main focus of the Project Assistant is to provide support to the members of the clinical project team, in order to facilitate management of clinical trials. The Project Assistant will ensure that the Project Manager is reinforced in the implementation, maintenance, and close-out of research trials. Project Assistant is expected to have working knowledge of databases and programs and perform administrative tasks to back the team members with clinical trial execution as needed. PRINCIPAL DUTIES AND RESPONSIBILITIES: Effectively utilizes databases and programs as deemed necessary. Maintains clinical project files to internal standards and regulatory requirements. Contributes to the preparation of presentations and reports. Ensures study documents meet FDA/ICH/GCP guidelines. Collects and prepares information for use in discussions/meetings. Attends and records minutes for internal and external clinical meetings. Provides recordkeeping and reporting to support investigator payments for assigned projects. Prepares, track and review patient payments Collects enrollment of patients to assure each subject is flagged appropriately in the systems. Effectively communicates with internal and external personnel, as well as clients and vendors. Establishes and maintains trial master files (i.e., hard copy and electronic folder set-up, filing, tracking, archiving) in compliance with SOPs, ICH and GCPs. Creates and maintains study tracking documents. Collects study documents from investigative sites, reviews and prepares document submissions to review boards for approval Tracks and assists with study start up activities Tracks study specific training at site and facility level Tracks the SVP review and approvals for study conduct at sites and tracks corporate review and approvals for study conduct at facilities. Maintain sponsor/study-required databases. Creates and maintains study tracking documents Liaise with internal data management team to trouble shoot issues on data deliverables Develops and implements study-related materials and coordinates distribution to sites. Assists with development of tools that can be utilized across studies. Provides solutions to routine project questions and issues related to project milestones and deliverables to ensure that projects remain on schedule, while meeting quality expectations and client satisfaction goals. Under general supervision, follows established company policies and procedures and applies acquired job skills. Drives issues to closure, despite obstacles and opposition. Maintains positive attitude throughout process. Performs functions that require full knowledge of general aspects of the job. May be asked to perform assignments requiring considerable research and initiative. Provides review of site regulatory documents for compliance with ICH GCPs and FDA guidelines and regulations related to clinical trials. Provides PM support for project timelines, action item follow-up, monthly reporting requirements and technical Provides administrative support, including document preparation, scheduling, and meeting coordination May be assigned specifically to one or more distinct projects which supports Project Manager and team. Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Assists with various projects as assigned by direct supervisor. Must maintain confidentiality and a high degree of sensitivity inside and outside of the company. Other duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Travel 10% or less. Availability outside of office hours required as needed (through e-mail, phone, etc.) EDUCATION: Required: Bachelor's degree in subject matter relevant to the position (if no Bachelors, then 5 years of direct relevant experience in a similar role in the Pharmaceutical/Biotech or Device industry) Participation in and documentation of training on GCP/ICH Guidelines and FDA regulations for clinical trials in the drug, biotech or device industry. EXPERIENCE AND REQUIRED SKILLS: 1 - 2 years' related experience (Project Assistant). Familiarity with study compliance (FDA ,ICH GCP) and local regulations. Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance required. Advanced computer proficiency, especially MS Office. Ability to multi-task, work independently, take initiative, and complete tasks to deadline. Excellent oral and communication skills. Superior customer service skills. Excellent time management and organizational skills. Experience with an electronic Clinical Trial Management System preferred.

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. *********************************************

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