Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
At Galderma, we’re unique and we embrace difference.
Whether it’s the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products, or our commitment to recognising and rewarding people for the contribution they make – working here isn’t like anywhere else.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Senior TMF ManagerLocation: London
About the Role
The Senior TMF Manager provides strategic leadership and hands-on oversight of the Trial Master File (TMF) across multiple clinical trials. This role is central to ensuring a high-quality, inspection-ready TMF, with a strong focus on eTMF system implementation, governance, and continuous improvement.
As the TMF Subject Matter Expert (SME), you will drive standardization, define best practices, and ensure compliance with global regulatory requirements (ICH-GCP, FDA, EMA). You will work cross-functionally and with external partners to elevate TMF quality, consistency, and operational efficiency across the organization.
Key Responsibilities
eTMF System Strategy & Governance
Lead the selection, implementation, configuration, and migration of eTMF systems.
Define and maintain TMF taxonomy, metadata, naming conventions, and workflows.
Develop and standardize TMF index/templates across all clinical functions.
Create and maintain TMF Plans throughout the study lifecycle.
Establish robust TMF governance frameworks in collaboration with IT and external vendors.
Develop sponsor oversight models and eTMF templates to ensure consistency and compliance.
Quality & Inspection Readiness
Ensure TMF compliance with ICH-GCP and global regulatory requirements (FDA, EMA).
Drive inspection readiness strategies across studies and programs.
Support internal audits and regulatory inspections as TMF lead/SME.
Metrics & Continuous Improvement
Define, track, and analyze TMF KPIs and performance metrics at study, portfolio, and vendor levels.
Identify trends, risks, and improvement opportunities based on data insights.
Lead process optimization initiatives, including enhancements to TMF SOPs and controlled documents.
Evaluate vendor performance related to TMF quality and documentation standards.
Cross-Functional Collaboration
Act as the TMF SME across Clinical Operations, Quality, Regulatory, and external partners.
Collaborate with functions such as Data Management, Biometrics, Safety, and Clinical Supply to standardize TMF practices.
Ensure alignment between TMF, CTMS, LMS, and other clinical systems.
Train, mentor, and support internal teams and CRO partners on TMF processes and best practices.
Qualifications
Education
Bachelor’s degree in Life Sciences or a related field (required).
Advanced degree (e.g., MSc, PhD) preferred.
Experience
8+ years of clinical research experience, including 5+ years in TMF management.
Proven track record leading eTMF system implementations and migrations.
Experience working with leading eTMF platforms (e.g., Veeva Vault).
Demonstrated experience supporting FDA and EMA inspections.
Skills
Deep knowledge of ICH-GCP, TMF regulations, and clinical development processes.
Strong understanding of the clinical trial technology ecosystem (e.g., TMF, CTMS, LMS integrations).
Excellent analytical skills, with the ability to interpret data and define meaningful TMF metrics and benchmarks.
Strong leadership, communication, and stakeholder management capabilities.
Why Join This Role
High-impact position shaping TMF strategy and standards at a global level.
Opportunity to lead system implementations and drive operational excellence.
Exposure to cross-functional collaboration and regulatory-facing activities.
What we offer in return
At Galderma, you will have the opportunity to lead regional operations across multiple markets and gain visibility across both local and global teams. You’ll be part of a collaborative, cross-functional environment with the autonomy to make a real impact on the business.
We offer a hybrid working model, professional development opportunities, and the chance to be part of a global organization committed to operational excellence and continuous improvement.
Next Steps
If your application is successful and your profile is a match, you will be invited for:
A first virtual conversation with the recruiter. A virtual interview with the Hiring Manager. A final panel interview with the extended team.
Our people make a difference
At Galderma, you’ll work with people who are like you – and people who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos create the perfect environment for people to thrive and excel in what they do.
