Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies for ophthalmic diseases. AGTC is seeking a highly motivated individual to provide strategic and operational leadership of clinical research studies to ensure adherence to intended timelines, budget and achievement of study goals while ensuring high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. The CPM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand implications of decisions that affect study outcomes and timelines.
- The Clinical Trial Manager reports to the Vice President, Clinical Development Operations.
Essential Duties and Responsibilities
Job responsibilities will include, but are not limited to, the following.
- Leads matrix, multi-disciplinary, cross-functional study execution teams from start-up through close to ensure both internal and external deliverables are on time and on budget.
- Develops the TMF quality control plan. Oversees the management of the electronic Trial Master File (TMF), ensuring that the TMF is created, maintained, monitored and closed out in adherence to the TMF quality control plan and study timelines
- Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding external factors, including a focus on the KOL perspective and the competitive landscape.
- Actively participates in the development of department initiatives, including acting as lead on the development/definition of CDO SOPs and processes; makes recommendations on how best to approach, manage and engage others on department initiatives. Develops and seeks ways to improve CDO project management processes and SOPs
- Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, data collection, clinical supplies) with other AGTC functions to support clinical trial delivery in alignment with study timelines and goals.
The successful candidate will meet the following requirements.
- B.S. degree in a scientific discipline or equivalent experience.
- Minimum 3 years’ experience managing clinical trials vendors at a sponsor
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug-free workplace. Please send CV or resume to: email@example.com