Gilead Sciences
Clinical Trials Manager
United States - California - Foster City
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About the role
- Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas.
- You will define and incorporate study logistics and study plans to accomplish clinical study objectives.
- You may also participate in strategic initiatives / projects.
Responsibilities
- Manages a geographical (region)s of assigned clinical studies, multiple components of larger studies, or all components of small clinical studies, including Phase 1 studies.
- Manages actively clinical study budgets and exercises proactive financial oversight.
- Collaborates with other functions on how to best achieve their study goals and objectives and communicates cross-functionally to ensure project team goals are met.
- With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, oversees and/or manages interactions and deliverables from relevant CROs, subcontractors, and vendors.
- Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits, defines study logistics and oversees/ develops clinical study plans for assigned clinical studies.
- Manages study timelines, including documentation and communications.
- Participates and/or acts as a Business Lead in initiatives / projects and manages project meetings and conference calls with CROs, other vendors and cross-functional teams as appropriate.
- Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
- Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
- Proactively identifies potential operational challenges and collaborates with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
Requirements
- MA / MS / PharmD / PhD with 3+ years' relevant clinical or related experience in life sciences.
- BA / BS / RN with 5+ years' relevant clinical or related experience in life sciences.
- Multiple years' clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
- Experience managing the work of external vendors.
- Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
- May be required to present at internal or external meetings (i.e., investigator meetings).
Nice to have
- Demonstrated ability to be a fast learner.
- Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
- Fully understands protocol requirements and effectively articulates and interprets these.
- Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation
- of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
- Ability to communicate in a clear and concise manner.
- Ability to execute multiple tasks as assigned.
- When needed, ability to travel.
Compensation
- $146,540.00 - $189,640.00.
- $133,195.00 - $172,370.00.
- Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
- These considerations mean actual compensation will vary.
- This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits
- include company-sponsored medical, dental, vision, and life insurance plans*.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
- We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Company info
- At Gilead, we're creating a healthier world for all people.
- Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
- As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
This listing is sourced directly from Gilead Sciences's careers page and normalized into a canonical job model.