Translate Bio is seeking an experienced and energetic Clinical Trial Manager to join our growing Clinical Operations team. This candidate will report directly to the Head of Clinical Operations. The CTM will be responsible for overseeing all aspects of clinical trial activities on assigned studies. This will include managing outside vendors in the execution of clinical trials and development of relationships between the Sponsor and site personnel.
The CTM will be responsible for a broad scope of varying activities to support department and corporate goals. Primary responsibilities for this position are to:
- Plan and implement 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 manuals, ICFs, and designing CRFs.
- Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
- Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data.
- Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
- Review and negotiate contracts & budgets.
- Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
- Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
- Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
- Limited travel possible to field sites to supervise and/or monitor clinical studies (<25%).
- Minimum of 5 years industry experience, specifically experience designing and managing a clinical trial from start to finish; Experience in rare diseases is highly desirable.
- BA/BS degree or equivalent in a health science field required
- Strong oral and written communication skills with monitoring, study management, and SOP-development experience.
- Highly adaptable, proactive, deadline- and detail-oriented, and able to maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications.
- Quality (GCP) and/or Data Management experience is required.
- Ability to work independently under general direction in a fast-paced environment.
Additional Preferred Qualifications
- Phase I and II experience preferred
- Rare Disease experience preferred, but are open to candidates with other TAs
- Small company and small studies experience preferred
- Must be able to hit the ground running
- Vendor management experience desirable