Clinical Research Manager

Role & Responsibilities
• Act as the main point of contact (POC) for assigned clinical trial protocols within the country
• Manage end-to-end execution of assigned clinical studies from feasibility to close-out
• Ensure compliance with ICH-GCP, country regulations, company SOPs, and quality standards
• Monitor study performance, timelines, deliverables, and recruitment targets
• Review monitoring visit reports and escalate performance and training gaps
• Conduct quality control visits as required
• Lead and train local study teams and support CRAs as protocol experts
• Develop and implement local risk management plans
• Ensure compliance with CTMS, eTMF, and other clinical systems
• Collaborate with investigators, CROs, and outsourcing partners
• Represent the company to investigators and external stakeholders
• Support budget management, contract approvals, and regulatory coordination
• Collaborate with HQ, pharmacovigilance, medical affairs, and regional teams
• Share best practices and support strategic planning initiatives

Qualifications
• Bachelor’s degree in Science or equivalent
• Master’s / MD / PhD preferred
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial operations

Experience
• 5–6 years of clinical research experience
• Prior CRA experience preferred
• Proven experience in managing multi-site or multi-country clinical studies

Skills
• Clinical trial project management
• Site management and monitoring
• Regulatory compliance and submissions
• Risk management and quality control
• CTMS and eTMF systems
• Leadership and team coordination
• Communication and stakeholder management
• Conflict resolution and decision-making
• Resource allocation and strategic planning

About the Company
• MSD is a global biopharmaceutical leader dedicated to discovering, developing, and delivering innovative medicines and vaccines that help improve health and save lives worldwide