Sr. Clinical Trial Coordinator

Roles & Responsibilities
• Track essential documents, safety reports, and maintain CTMS and clinical trial databases
• Manage clinical and non-clinical supply logistics and coordinate labeling and translation change requests
• Ensure site readiness within planned study timelines
• Prepare, collate, distribute, and archive clinical trial documentation
• Execute eTMF Quality Control Plan and perform eTMF reconciliation
• Prepare Investigator Trial File (ITF) binders and ensure Good Documentation Practices (GDP) compliance
• Support IRB/ERC submission package preparation and coordinate regulatory authority submissions
• Track study insurance certificates and assist in publishing study results as per local regulations
• Develop and manage site budgets and negotiate Clinical Trial Agreements (CTRA)
• Track contract lifecycle management (CLM) and process investigator payments and grants
• Ensure compliance with FCPA documentation requirements
• Act as Subject Matter Expert (SME) and mentor junior CTCs
• Drive process improvements and support investigator meetings and study coordination

Qualification
• B.Pharm / M.Pharm / Pharm.D / Life Sciences
• Bachelor’s Degree in Healthcare / Clinical Research / Administration preferred

Experience
• 3–5 years of experience in Clinical Research or Healthcare
• Hands-on experience with CTMS, eTMF, IRB/ERC submissions, and Clinical Trial Agreements
• Strong knowledge of ICH-GCP and Clinical Trial Compliance

Skills
• Strong MS Excel and overall IT proficiency
• Expertise in clinical trial documentation and eTMF management
• Knowledge of GCDMP and regulatory compliance standards
• Budget negotiation and contract management skills
• Strong time management and multitasking abilities
• Effective communication and stakeholder coordination skills
• Ability to work in a global, matrix-driven environment

About the Company
MSD (Merck Sharp & Dohme), known as Merck & Co., Inc., USA, is a global healthcare leader committed to advancing clinical research and innovative medicines. Through its Global Clinical Trial Operations (GCTO) team, MSD delivers high-quality, compliant clinical studies worldwide. The organization offers strong career growth, structured mentorship, and exposure to global clinical trial management within a multicultural and compliance-driven environment.