Clinical Trials Manager
About The Position
This role will be based out of our Parsippany, NJ location OR Foster City, California. We are seeking a Clinical Trials Manager (CTM) to support the Oncology 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.
Requirements
- 5+ Years with BS/BA in a relevant scientific discipline.
- 3+ Years with MS/MA in a relevant scientific discipline.
- Prior Oncology experience.
- Prior CRO/Pharma/Biotech experience.
Nice To Haves
- Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
Responsibilities
- Coordinating 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 manage CROs/vendors or 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 /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.
- 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 to generally understand, interpret, and explain protocol requirements to others.
- Must be able to prioritize multiple tasks.
- May serve as a resource for others within the company for clinical trials management expertise.
- Under general supervision, is able to examine functional issues from an organizational perspective.
- Must have general, functional expertise to support SOP development and implementation.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans.
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
