Clinical Trial Manager
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About the role
The Clinical Trial Manager (CTM) will work collaboratively across cross-functional teams with Project Management, Clinical Operations, Data Management, Medical Monitoring, Pharmacovigilance, and Regulatory Affairs while understanding and managing client expectations. The Clinical Trial Manager is responsible for the day-to-day management of clinical aspects of projects, including communication and interaction with clinical sites, CRAs, and third-party vendors. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring; accountability of clinical monitoring compliance, tracking of critical project tasks; strategic study enrollment support including project-specific enrollment planning and clinical team accountability. This role will be responsible for the identification, resolution/mitigation, and escalation of risks related to site management and monitoring of the trial.
Key responsibilities
- Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant
- Collaborate with the Project Manager to prepare, organize, and present investigator meetings
- Deliver documents and study materials for the clinical department promptly
- Generate the Clinical Monitoring Plan
- Establish and maintain tracking tools for assigned trials and ensure maintenance of relevant sections of the Trial Master File and Project Status Reports
- Perform reviews of monitoring visit reports and confirm alignment with the timeline
- Proactively identify and resolve issues and participate in process improvement initiatives
- Develop and track timelines, budget, quality, and performance metrics for clinical operational activities
- Manage study investigators, study sites, clinical monitors, clinical field specialists, and any assigned vendors
- Conduct regular meetings with the Clinical Research Associates, and actively participate in team meetings with functional leads to assess and mitigate emerging or potential risks
About you
- Bachelor's degree or its international equivalent, preferably in nursing or life science. In lieu of a degree, an equivalent combination of education and relevant work experience is required
- At least two (2) years of experience managing clinical trials within a CRO
- Five (5) or more years of monitoring experience required or relevant experience in lieu
- Extensive knowledge of relevant international regulations and guidelines, ICH GCP, and other relevant GCP guidelines for clinical trial management
- Prior experience in electronic data capture (EDC) and electronic clinical trial management (CTMS) systems is required
- Strong knowledge of clinical trial processes
- Knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management
- Strong communication skills (verbal and written) to express complex ideas
- Excellent organizational and interpersonal skills
- Ability to mentor and train clinical staff
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