Clinical Trials Manager

Gilead Sciences•Foster City, CA

3d•$146,540 - $189,640•Hybrid

About The Position

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will typically manage Late Phase studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives/projects. This is a site-based position (Tuesday- Thursday) at our Foster City, CA campus.

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 complex studies and project teams.
Experience managing the work of CROs and external vendors.

Nice To Haves

Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Ability to manage any component of full cycle study management, from start-up to close-out.
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 FDA, EMEA, and other applicable national regulations, ICH guidelines, and GCPs governing the conduct of clinical studies.
Familiar with standard medical /scientific terminology.
Ability to communicate in a clear and concise manner.
Ability to support a team-oriented, highly matrixed environment.
Ability to execute multiple tasks as assigned.
Ability to travel when needed.

Responsibilities

Manage a geographical (region)s of assigned clinical studies, multiple components of larger studies, or all components of smaller clinical studies, including Late Phase studies.
Actively manage clinical study budgets and exercise proactive financial oversight.
Collaborate with other functions on how to best achieve study goals and objectives and communicate cross-functionally to ensure project team goals are met.
With guidance, leads contract research organization (CRO) and vendor selection and, where applicable, trains, oversees and/or manages interactions and deliverables from relevant CROs, subcontractors, and vendors.
Serve 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.
Define study logistics and oversee/develop clinical study plans for assigned clinical studies.
Manage study timelines, including documentation and communications.
Participate and/or acts as a Business Lead in initiatives/projects and manage project meetings and conference calls with CROs, other vendors and cross-functional teams as appropriate.
Contribute to SOP development and/or participate in special projects.
Develop tools and processes that optimize project efficiencies and effectiveness.
Provide input into study protocols, case report forms, and informed consents, final study reports, oversee/author study plans, and presentations.
Coordinates review of data listings and preparation of interim/final clinical study reports.
May contribute to development of abstracts, presentations, and manuscripts.
Provide oversight of study sites/region and review routine regulatory documents to ensure that CROs /vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
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).
Lead or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
Proactively identify potential operational challenges and collaborate with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
Assists in training new or less experienced colleagues.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements