Senior Clinical Trial Manager
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
Tech Stack
About the role
- Manages all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are met
- Manages study-related service providers and serves as the primary point of contact for contracted CROs, study staff, and contract labs as appropriate
- Identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate
- Participates in CRO selection process, validates clinical scope of work, supports auxiliary service outsourcing, provides input into vendor management plan, reviews quality metrics, and shares lessons learned as required
- Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial execution
- Reviews and oversees the development, review, and operational aspects of site investigator grants and grant payment in accordance with sponsor process requirements
- Coordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meeting
- Leads and/or supports clinical operational team meetings in support of the respective clinical trial including drafting agenda, collecting minutes, filing minutes in the TMF, tracking action items, providing ongoing status of trial enrollment and timelines, outlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners
Requirements
- Minimum of 5 years of demonstrated direct responsibility for clinical study leadership in the biopharmaceutical industry
- Global clinical trial experience is strongly preferred
- Demonstrated ability to independently lead a clinical study from startup activities through data base lock and regulatory submission(s)
- Advanced experience in management of contracted resources/CROs, site monitoring and clinical quality compliance
- Strong CRO oversight and operational management skills with proven attention to detail required
- Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials
- Applies knowledge of GCP/regulatory requirements to all aspects of study preparation and oversight
- Documented experience with data safety monitoring board (DSMB) activities
Benefits
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementCRO managementsite monitoringregulatory submissiondata safety monitoring board (DSMB)Good Clinical Practices (GCP)FDA regulationsvendor managementquality compliancerisk management
Soft Skills
leadershipcommunicationattention to detailproblem-solvingorganizational skillsteam collaborationmeeting facilitationagenda developmenttrainingstakeholder management