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 coordinate all clinical trial activities and will be responsible for managing the daily study activities to ensure study team members understand the project deliverables and are adhering to timelines and budget. The CTM is fully accountable for oversight of site activities as well as for all aspects of monitoring team performance such as patient recruitment, quality of the clinical data and compliance with SOPs and GCP.
- 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.
- Thoroughly understands clinical trial protocols and site specifications and manages the oversight of the data delivery process in clinical trials ensuring consistency with protocols, including participation in data review/reconciliation efforts.
- With minimal oversight from CPM, manages vendor site monitoring and oversees monitor performance including development of the study monitoring plan and oversight of activities at the study level. Responsible for site monitoring report review as well as adherence to the study monitoring plan and applicable SOPs and processes. Proactively communicate issues to the CPM.
- Responsible for managing the creation, maintenance and close out of Trial Master File (TMF) activities. Contributes to TMF quality plan development. Performs QC of Trial Master Files.
- Manages elements of the quality plan (e.g., inspection readiness, compliance); diligently follows AGTC Clinical Development Operations SOPs; identifies gaps, and works with other senior Clinical Development Operations staff or independently to eliminate those gaps
- Conducts oversight of sample definition, collection, and analysis at the study level and ensures the link back to the program level sample (biomarker, PD) strategy
The successful candidate will meet the following requirements.
- B.S. degree in a scientific discipline or equivalent experience.
- Minimum 2 years’ experience managing clinical trials at a sponsor or CRO
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: firstname.lastname@example.org