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.
Job Scope
The Clinical Trial Associate supports the planning, execution, and coordination of clinical development activities across various functional areas, including clinical operations, outsourcing, medical experts, project management, pharmacology, supply, and biometrics. This entry-level role assists in the evaluation of product safety, efficacy, and marketability while maintaining adherence to timelines, protocols, and regulatory requirements.
Skills & Qualifications
- Implement clinical development programs and plans to support operational and scientific activities.
- Attend study team and vendor meetings, and maintaining the study Action, Decision, Issue (ADI) logs, finalizing, and distributing to the study teams
- Responsible for assisting with the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are entered into the appropriate clinical systems
- Lead study TMF filing, management, oversight, & reconciliation activities, including interaction and coordination of all essential internal TMF contributing functions and the responsible CRO according to ICH-GCP, company SOPs and WIs
- Overall responsibility of Trial Master File (TMF): set up, maintenance and archiving for clinical studies: For out-sourced studies, controls administrative work ensuring CRO maintains a complete trial master file and organized shipment to Galderma in the appropriate format at the end of the study
- For in-sourced studies, assures filing on an ongoing basis of a complete TMF (including insurance, translations, approvals, etc.)
- Completes TMF Quality Control and subsequent Quality Assurance audit resolution in collaboration with Clinical Team
- Assures administrative archiving of the TMF
- Ensures consistency and set up between all outsourced studies to our TMF structure
- Setup and Ensure in conjunction with the Clinical Trial Manager (CTM) that study related systems (CTMS, eTMF, Smartsheets) are updated on a regular basis
- Assist study team in managing study start-up, conduct and close-out activities and other project related activities
- Support clinical trial insurance activities including the filing and tracking of new country policies and renewals
- Ensure study training tracking and reconciliation is completed in joint with the Clinical Trial Manager (CTM)
- Assist the CTMs/Study Teams in preparation of Audits or Inspections and participate in Audit and Inspection interviews, as required
- Assist study team in the conduct of studies and ensure they are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures
- Assist with oversight of operational activities from start-up to close-out to ensure deliverables are prioritized and goals and objectives are met
- Assist with the development and review of study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, laboratory and pharmacy manuals, data management plans, etc.
- Assist the study team with report creation and review for study metrics and/or KPIs
- Collaborate with internal and external team members for the planning and execution of clinical trials
- Assembles final clinical study report appendices; ensure final report completeness in collaboration with Clinical Team
- Maintains reporting and managing document lifecycles in electronic document management system (EDMS)
- Assists in the set up and maintenance of public registries
- Helps with formatting documents (i.e., protocols, amendments, letters, plans, etc.), as needed
- Support Inspection Readiness activities for priority projects, as assigned, including coordination of study oversight activities
- Contribute to workshops / special initiatives as Subject Matter Experts
- Maintain Study Team Rosters and Study related system access
- Maintain knowledge and usage of databases and platforms used by the department
- Other duties as assigned
- Ensure all activities follow SOPs, GCP, and relevant country-specific regulations.
Preferred Skills and Qualifications
- Bachelor’s degree or equivalent experience in life sciences, clinical research, or related field.
- Less than 2 years of relevant professional experience.
- Basic understanding of clinical trial processes, SOPs, and GCP guidelines.
- Ability to navigate and manage stakeholder relationships
- Detail-oriented with the ability to follow established procedures.
- • Excellent verbal and written communication, interpersonal, organizational, and time management Proficiency in standard office software (e.g., Microsoft Word, Excel, Outlook, Teams, Sharepoint).
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