The Clinical Trial Manager (CTM) is responsible for leading one or more Study Management Teams (SMTs).
The CTM is responsible for the day-to-day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites. The CTM is also accountable for ensuring high quality deliverables are within timelines and budget.
Responsibilities
Responsible for the day to day management and oversight of assigned operational aspects, such as CRO/vendor management, drug supply management, clinical sites, etc.
Lead cross-functional SMT meetings
Support the Program Lead during the Protocol Development process
Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
Conduct protocol and site feasibility assessments
Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
In collaboration with Clinical Procurement and Outsourcing, provide leadership in the selection of vendors, including CRO, central lab, imaging, etc.
Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, Vendor Management Plan, Risk Management Plan, eCRF Completion Guidelines, etc.)
Provide drug supply assumptions to the clinical planning team
Develop and maintain study timelines, enrollment dashboards, and budgets
Serve as a liaison and resource for clinical trial sites
Oversee the creation and maintenance of the Trial Master File
Perform site initiation, routine monitoring and close-out visits, as well as co-monitoring with CRAs as needed
Review site visit reports
Participate in the development, review and implementation of departmental SOPs and processes
Qualifications
Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams
Working knowledge of ICH Good Clinical Practice guidelines
Experience with international trials is preferred
Able to handle multiple tasks and deadlines
Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
Highly effective verbal and written communication skills
Must have the ability to build and maintain positive relationships with management, peers and clinical sites
Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
Willing to travel domestically and internationally
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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