Backed by GV.
About the role
We are seeking a Senior Clinical Trial Manager with relevant Clinical Operations experience to join our growing Clinical Development group who will be responsible for providing trial management support for our oncology programs. This role will report to the VP, Clinical Operations.
What they're looking for
- Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
- 5-8+ years of trial management experience as primary Clinical Trial Manager (or equivalent) within Pharma, Biotech or CRO, Oncology experience required
- Strong understanding of global regulatory and compliance requirements for clinical research
- Strategic understanding of how outcomes, budgets, and timelines are impacted by decisions
- Outstanding teamwork, organizational, interpersonal, and problem-solving skills
- Effective communicator both verbally and in written form
More about this role
Senior Clinical Trial Manager
We are seeking a Senior Clinical Trial Manager with relevant Clinical Operations experience to join our growing Clinical Development group who will be responsible for providing trial management support for our oncology programs. This role will report to the VP, Clinical Operations. Job responsibilities include, but are not limited to, preparation of study related materials, enrollment tracking and reporting, relationship management with study sites and vendors (in particular CROs), supervision of study-related activities, identification of project risks and contingency planning.
- Clinical Operations point of contact for execution of clinical studies in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
- Manage clinical CRO(s) and other study vendors from initial contact through to final study deliverables.
- Lead external (CRO) trial management team, to ensure conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Ensure coordination of the CRO activities are timely, coordinated and complete, including but not limited to clinical...
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