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GS
Gilead Sciences
Clinical Trials Manager- Late Phase Oncology (Office-Based)
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What they do
A Clinical Trial Manager is responsible for planning and managing all aspects of an organization's program of clinical trials, usually for an organization undertaking pharmacological drug testing.
$183,783 / year median in California
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer
- working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
- 19 and cancer
- working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
Job Summary :
We are seeking a Clinical Trials Manager (CTM) to support the O ncology pipeline. The CTM d rives end-to-end operational delivery of Phase II and III oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight. This role serves as a key contributor for study execution and study management by coordinating with the internal teams and external partners (including CROs and vendors ), and ensuring alignment across all stakeholders to achieve study objectives . The CTM applies strong project management, clinical, and regulatory expertise to proactively identify risks, implement solutions, and maintain s study timelines to meet the study deliverables for the in-house and/or hybrid model clinical trials. Prior Oncology experience and prior CRO/Pharma/Biotech experience is required .Job Description/ Key responsibilities:
Coordinat ing and supervising all aspects of clinical study. Assists Clinical Program Manager in the overall study management. Provide input into study protocols, investigator brochures , case report forms, and informed consents, final study reports, oversee/author study plans, and presentations. Maintains study timelines. including documentation and communications. Contributes to development of study budget. Contributes to development of RFPs and participate in selection of CROs/vendors. May m anage CROs/vendors or functional service providers . May s erve 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. 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. Ensures effectiveness of site budget/contract process. May be asked to train CROs, vendors, investigators, and study coordinators on study requirements. Coordinates review of data listings and preparation of interim/final clinical study reports and appendices , including resolving any data discrepancies. Assists in determining the activities to support a project's priorities within functional area. Develop tools and processes that optimize project efficiencies and effectiveness. Travel is required . Excellent teamwork, communication, decision- making and organizational skills are required .
People Leader Accountabilities:
Create Inclusion- knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent
- understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams
- connect the team to the organization by aligning goals, purpose, and organizational objectives , and holding them to account.
Bay Area:
$146,540.00- $189,640.
Other US Locations:
$133,195.00- $172,370.
- . For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.