Clinical Trials Manager

About the role

• 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 clinicalstudy plans for assigned clinicalstudies.
• 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.
• Provides input into study protocols, case report forms, and informed consents, oversees/authors study plans, and presentations.
• Provides oversight ofstudy sites/region and reviews 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).
• Leads or otherwise assists in the preparation ofsafety, 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.
• Assists in training new or less experienced colleagues.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements

Requirements

• BA / BS / RN with 5+ years' relevant clinical or related experience in life sciences.
• MA / MS / PharmD / PhD with 3+ 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.

Pay and benefits

The salary range for this position is: $146,540.00 - $189,640.00. 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*.

For additional benefits information, visit

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Your Rights Under the Family and Medical Leave Act

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

• Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
• Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.