Senior Clinical Trial Manager
About The Position
Galderma is seeking a Senior Clinical Trial Manager (CTM) to plan and manage overall activities for assigned global clinical trial(s). This includes timelines, budgets, resources, investigational sites, vendors, and key deliverables. The role ensures compliance with SOPs, regulatory requirements, and ICH/GCP guidelines, aligning with company strategies and goals. The Senior CTM may lead other CTMs depending on the scope of the clinical trial. Galderma is a global leader in dermatology, focused on delivering innovative, science-based products across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. They value individuals who are results-oriented, embrace learning, possess positive energy, and combine initiative with teamwork and collaboration. Passion for making a meaningful impact on consumers, patients, and healthcare professionals is essential. The company aims to empower employees, promote personal growth, and foster diversity and respect.
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 a 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 coverage
- dental coverage
- vision coverage
- 401(k) plan with employer match
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
