Senior Clinical Trial Manager
About The Position
Galderma is a leading company in the dermatology sector, operating in approximately 90 countries. They offer an innovative, science-based portfolio across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Founded in 1981, Galderma is dedicated to skin health and aims to meet individual needs with superior outcomes in partnership with healthcare professionals. The company values employees who are results-oriented, embrace learning, possess positive energy, initiative, teamwork, and collaboration, and are passionate about making a meaningful impact. Galderma strives to empower employees, promote personal growth, and ensure business needs are met, while embracing diversity and respecting employee dignity. They aim to be the world's leading dermatology company, offering opportunities for challenging work experiences and direct impact.
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%
Nice To Haves
- systemic drug and biologics experience preferred
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
- 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 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
