Clinical Trials Manager- Late Phase Oncology

Job Summary

Clinical Trials Manager (CTM) to support the Oncology pipeline. Drives end-to-end operational delivery of Phase II and III oncology trials, ensuring high-quality execution through cross-functional leadership and CRO/vendor oversight. Coordinates internal teams and external partners to align stakeholders and achieve study objectives.

• Coordinate and supervise all aspects of clinical studies; assist Clinical Program Manager in overall study management.
• Provide input into protocols, investigator brochures, case report forms, informed consents, final study reports; oversee/author study plans and presentations.
• Maintain study timelines, including documentation and communications.
• Contribute to study budget development; develop RFPs and participate in selecting CROs/vendors.
• May manage CROs/vendors; may serve as key operational contact (site evaluation, initiation, close-out, and oversight monitoring).
• Ensure study sites/regions and regulatory documents meet protocols, regulatory requirements, SOPs, and monitoring plans.
• Ensure effectiveness of site budget/contract process.
• May train CROs, vendors, investigators, and study coordinators.
• Coordinate review of data listings and preparation of interim/final clinical study reports and appendices; resolve data discrepancies.
• Develop tools/processes to optimize project efficiencies; travel required.

• Prior Oncology experience and prior CRO/Pharma/Biotech experience required.
• Thorough knowledge of FDA and/or EMEA regulations, ICH guidelines, and GCPs is desirable.
• Must be able to understand/interpret/explain protocol requirements; prioritize multiple tasks.
• 5+ years with BS/BA in a relevant scientific discipline OR 3+ years with MS/MA in a relevant scientific discipline.

• Create Inclusion;
  Develop Talent;
  Empower Teams.

• May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.