Clinical Trial Operations Manager

4 weeks ago

Watertown, Massachusetts, United States Affini-T Full time
About Affini-T Therapeutics
A clinical stage biotechnology company focused on developing a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, we focus on enhanced T-cell fitness to overcome the immunosuppressive tumor microenvironment.

Job Summary
The Clinical Trial Manager will play a key role in leading and supporting all aspects of clinical trial execution and management. The successful candidate will bring a significant capability to deliver on the operational needs of the clinical programs while possessing a thoughtful perspective, drive for results, and the ability to work with, influence, and communicate with a variety of stakeholders. The successful candidate must be comfortable working independently, managing interactions with both internal and external partners, and ensuring that the clinical trials are managed to the highest quality to assure the safety and effectiveness of Affini-T's products.

Key Responsibilities
  • Support the implementation of clinical research studies within budget and on schedule.
  • Manage activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
  • Coordinate and lead study team meetings and update the Clinical Team on timelines and milestones for the study.
  • Contribute to the development of study documentation, including protocol review, creating study operations manuals, ICFs, and designing CRFs.
  • Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
  • Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, and motivational visits as needed.
  • Provide Sponsor oversight of CROs and vendors to assure integrity of clinical data with respect to accuracy and accountability through review of case report forms, source documents, medical records, etc.
  • Ensure study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house.
  • Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities in accordance with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
  • Train team members, site staff, and vendors as needed.
  • Limited travel possible to field sites to supervise and/or monitor clinical studies (~25%).
Requirements
  • BS/BA or equivalent in science or a health-related field is preferred.
  • Minimum of 5 years of relevant industry experience within clinical operations and 1+ year of trial/project management.
  • Experience in oncology clinical trials, preferably in solid tumors and/or in cell therapy.
  • Experience with all aspects of trial and site startup, vendor management, study management, and site monitoring.
  • Familiarity with clinical data review and data management processes.
  • Excellent knowledge of GCP, ICH, and FDA regulations.
Attributes
  • Excellent interpersonal and communication skills.
  • Strong attention to detail and organizational skills.
  • Work well independently and in collaboration across various teams in the organization.
  • Self-starter, able to contribute effectively in a fast-changing environment.
  • Highest integrity and work ethics.
  • Commitment to quality and timely delivery of results.

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