Senior Clinical Trial Manager
Galderma•Boston, MA
•Hybrid
About The Position
The Senior Clinical Trial Manager (CTM) plans and manages overall activities for assigned global clinical trial(s). This includes timelines, budgets, resources, investigational sites, vendors and key deliverables. This position ensures compliance with SOPs, regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals. The Senior CTM may lead other CTMs in the organization depending on the scope of the clinical trial.
Requirements
- University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
- Progressive experience in clinical research/operations (at least 5 years)
- Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
- Experience as manager of clinical trials in major market(s) such as US, China
- Experience in supervising CROs
- Excellent understanding of the drug development process, systemic drug and biologics experience preferred
- Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP
- Excellent knowledge of relevant local regulations
- Fluent in English (written and oral)
- Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 20%
Responsibilities
- Lead and manage cross-functional Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
- Work closely with the Clinical Science Experts and Clinical Scientists for the design of the clinical trials
- Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager
- Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines
- Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks
- Contribute to the reporting of clinical studies and clinical documentation to regulatory submissions according to plan and in compliance with applicable regulatory requirements, international standards and the company quality system throughout the development life cycle
- As applicable, provide oversight to Clinical Research Associates and Clinical Trial Administrators assigned to the clinical trial
- Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)
- Collaborate with Procurement to prepare clinical outsourcing specifications
- Participate in the selection of the CRO or FSPs
- Serve as the primary trial contact with the CRO and FSPs
- Ensure that all aspects of the trial are prepared for regulatory inspections at any time
- Serve as member of the inspection readiness team in preparation of a regulatory inspection
- Support the preparation for and conduct of investigational site and sponsor health authority inspections, as applicable
- Contribute to and initiate trial and departmental process improvement initiatives
Benefits
- medical, dental, and vision coverage
- a 401(k) plan with employer match
- paid time off
- other benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Senior
