Senior Clinical Trial Manager

EPM Scientific-posted 9 months ago
Senior
Piscataway, NJ
Administrative and Support Services
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A growing biotechnology company is seeking an experienced Sr. Clinical Trial Manager to oversee its clinical pipeline. This role involves full lifecycle clinical trial management, including study setup, execution, and oversight of CROs and vendors. The Sr. CTM will be a key contact for clinical study project management and operations, ensuring compliance with FDA, ICH-GCP, and internal SOPs. This position requires strong leadership skills and collaboration across multiple cross-functional teams, including safety, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, medical affairs, and quality. The ideal candidate thrives in a fast-paced, hands-on environment and has the ability to drive research and operational excellence.

  • Oversee all aspects of clinical trial execution, including study startup, conduct, and closeout.
  • Manage relationships with CROs and external vendors, ensuring high-quality study execution.
  • Develop and oversee study timelines, budgets, and operational efficiency metrics.
  • Lead cross-functional collaboration with teams including data management, clinical supplies, safety, and regulatory.
  • Participate in CRO meetings, internal study team calls, and operational strategy discussions.
  • Track study progress, identify risks, and implement mitigation strategies.
  • Ensure audit-ready documentation and compliance with GCP, FDA, and ICH regulations.
  • Support the development of study-related materials (protocols, informed consent, monitoring plans, etc.).
  • Maintain oversight of Trial Master Files (eTMFs).
  • Contribute to budget planning, forecasting, and financial management of clinical studies.
  • Work within a small biotech/startup environment, managing multiple priorities effectively.
  • Bachelor's degree (BA/BS) in a scientific or healthcare-related discipline.
  • 7+ years of clinical trial management experience within biotech, pharma, or CROs.
  • 3+ years of oncology clinical research experience required.
  • Experience in small biotech/pharma environments preferred.
  • Cell and gene therapy (CAR-T) experience is a plus.
  • Strong experience in CRO/vendor oversight for complex clinical studies.
  • Project management skills, with the ability to manage multiple studies simultaneously.
  • Familiarity with global regulatory processes for clinical trials.
  • Strong organizational and communication skills, with high attention to detail.
  • Ability to travel (~10-15%).
  • Experience in small biotech/pharma environments preferred.
  • Cell and gene therapy (CAR-T) experience is a plus.
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