Galderma · 2 days ago
Clinical Trial Manager
Boston, MA
Full-time
Onsite
Senior Level
5+ years expGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. The Clinical Trial Manager (CTM) plans and manages overall activities for assigned global clinical trials, ensuring compliance with regulatory requirements and alignment with company strategies while overseeing project milestones and managing risks.
Pharmaceuticals
Responsibilities
Partner with 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 Scientist 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
Qualification
Required
University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
Experience in clinical research/operations (≥5-7 years) or equivalent with Pharma/Biotech and/or CRO experience
Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
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)
Preferred
Excellent understanding of the drug development process, systemic drug and biologics experience preferred
Company
Galderma
Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Tom Christenson
Chief Financial Officer
Wendy Johnson
Vice President Strategic Partnerships and Professional Relations
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