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Gilead Sciences, Inc.
Clinical Trials Manager- Late Phase Oncology
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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.
$176,154 / year median in New Jersey
Job Description
Gilead Sciences, Inc.
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Clinical Trials Manager
- Late Phase Oncology Parsippany, NJ Posted 60 days ago Apply Now 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.
- 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 drives 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 maintains 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:
Coordinatingand supervising all aspects ofclinicalstudy. Assists Clinical Program Manager intheoverall 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 andparticipatein selection of CROs/vendors. May manage CROs/vendorsor functional service providers. May 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. Provide oversight of study sites/region and review routine regulatory documents to ensure that CROs /vendorsare in compliance withprotocols, 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 reportsand appendices,including resolving any data discrepancies. Assistsindeterminingthe activities to support a project's priorities withinfunctionalarea. Develop tools and processes thatoptimizeprojectefficienciesand effectiveness. Travel isrequired. Excellent teamwork, communication, decision-makingand organizational skills arerequired. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. Must be able togenerally understand, interpret, and explain protocol requirements to others. Mustbe able to prioritize multiple tasks. May serve as a resource for others within the company for clinical trials managementexpertise. Under general supervision,isable toexamine functional issues from an organizational perspective. Must havegeneral, functionalexpertiseto support SOP development and implementation. Basic qualifications : 5+ Years with BS/BAin a relevant scientific discipline. 3+ Years with MS/MAin a relevant scientific discipline.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 employeesare receiving the feedback and insight needed to grow,developand realize their purpose. Empower Teams
- connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account.
Bay Area:
$146,540.00- $189,640.
Other US Locations:
$133,195.00- $172,370.