We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRTTM), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.
The Clinical Trial Manager reports to the Director, Clinical Operations and is an integral part of the Clinical Operations team. This position offers opportunities to lead rare disease clinical studies leveraging cutting-edge mRNA technology. The Clinical Trial Manager is responsible for the management of assigned clinical studies.
- 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%).
Required Skills & Qualifications
- The Clinical Trial Manager has a minimum of 3 years industry experience, specifically experience designing and managing a clinical trial from start to finish.
- Experience in rare diseases is highly desirable.
- The CTM has a BA/BS degree or equivalent in a health science field.
- The CTM has strong oral and written communication skills with monitoring, study management, and SOP-development experience.
- The CTM is highly adaptable, proactive, deadline- and detail-oriented, and maintains 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.
- The CTM works independently under general direction in a fast-paced environment.