Clinical Trial Manager (CTM) Contract
About The Position
Jasper is a biotechnology company focused on enabling cures by targeting mast cells and stem cells. Our mission is to make safer and potentially curative therapy possible for most patients in need. We are bringing together a team of biotech veterans, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision of developing new therapies for diseases of mast and stem cells, safer and more effective conditioning for monogenic diseases and new engineered therapies. Position Summary: The CTM is accountable for successfully delivering the full scope of study activities including site activation, patient recruitment, study monitoring and site and vendor management. The role requires active leadership as the leader of the study execution team (SET) is expected to work cross-functionally with the entire team.
Requirements
- A minimum of a Bachelors’ degree.
- At least 5 years of clinical trial management experience in a Biotech, Pharmaceutical company, or Clinical Research Organization.
- Previous employment at a pharmaceutical or biotech company required.
- Demonstrated working knowledge of ICH/ GCP guidelines and FDA regulations.
- Excellent time management skills with the ability to prioritize to achieve assigned goals.
- Excellent verbal and written communication skills.
- Strong leadership skills and attention to details
Responsibilities
- Lead overall operational execution of a global clinical study from initial study synopsis through final project deliverables (study set-up, enrollment, conduct, database lock, final TLFs, CSR, etc.).
- Manage the implementation, on-time execution and conduct of clinical studies; contributing and tracking the development of budget items, milestones and timelines, in addition to contributing to the scope and management of resources (including vendor selection), leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
- Responsible for site feasibility and recruitment, including review of Site Information Questionnaires.
- Responsible for assigned clinical documents (i.e. protocols, ICFs, and manuals) for clarity and accuracy and following ICH/GCP guidelines.
- Responsible for assigned clinical study plans, including; Clinical Monitoring, Communication, Project Management and electronic Trial Master File (eTMF) Management.
- Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
- Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements.
- Responsible for CRO and vendor management as well as contributing to or leading the systems set-up/management including EDC, IRT, Central Laboratories, specialty services (ePRO, ECG, etc.).
- Effectively tracks and communicate program/study progress to the Study Execution Team and senior management with ability to create and update detailed dashboards and trackers.
- Represents department in a professional manner; build and establish good relationships with investigators and all other study personnel.
- Builds productive and collaborative relationships internally.
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What This Job Offers
Career Level
Mid Level
