Clinical Data Manager

4 weeks ago

Pune, India Whatjobs IN C2 Full time

I. Position Summary The Senior Clinical Data Manager (CDM) is the Subject Matter Expert (SME) responsible for leading and executing all clinical data management activities from study startup through database lock. This role ensures all deliverables meet the highest standards of quality, are completed on time and within budget, and comply with all Standard Operating Procedures (SOPs), current industry, and regulatory guidelines (ICH, GCP, GCDMP). The CDM serves as the technical leader and primary contact for client and vendor communications. II. Key Responsibilities A. Study Leadership & Project Management Independently manage the end-to-end delivery of Data Management services for single and multi-service clinical trial projects. Serve as the primary liaison for internal teams, clients, and vendors, ensuring clear and effective communication throughout the study lifecycle. Guide and mentor junior members of the Data Management team, including supervising and scheduling Data Management Associates. Ensure data lock activities are performed according to agreed timelines, budget, and quality requirements. B. Database Design & Setup (Design Phase Expertise) Serve as the technical expert for eCRF design, ensuring alignment with the study protocol and data management guidelines. Lead the execution of all study plans, from Data Management Plan (DMP) development through to database lock. Design, maintain, monitor, and lock databases for diverse trials, including Phase I (First-in-Human, PK/PD, SAD/MAD), Safety & Tolerability studies, utilizing various EDC systems. Apply in-depth knowledge of CDISC CDASH standards during database design and mapping. C. Data Validation & Processing (Conduct Phase Expertise) Oversee all data entry, data cleaning, and data

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