Senior Clinical Data Manager

Latinum HR Solutions · India

We are seeking an experienced Senior Manager – Clinical Data Management to lead and oversee clinical data management activities supporting global clinical development programs. The role involves managing in-house and outsourced data management activities, providing CRO and vendor oversight, ensuring data quality and timely delivery, and supporting regulatory submission readiness. The successful candidate will collaborate closely with Clinical Operations, Statistics, Statistical Programming, Therapeutic Area teams, CROs, and other cross-functional stakeholders to ensure high-quality clinical data management deliverables.

ROLE DETAILS

Location: PAN India

Experience: 7+ Years

Domain: Life Sciences / Bio-Pharma

Role: Senior Manager – Clinical Data Management

EDUCATION

Bachelor’s / Master’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Biochemistry, Statistics, or a related field.

Key Responsibilities

• Lead Clinical Data Management activities across in-house and outsourced clinical studies.
• Provide CRO and vendor oversight across global development programs.
• Represent Data Management within cross-functional clinical teams and ensure alignment on data-related deliverables.
• Lead clinical trial data collection setup, including EDC, IRT, ePRO and eCOA.
• Develop and oversee data cleaning plans, edit checks, data validation plans, data integration and transfer specifications.
• Lead data review, query management, and interim/final database lock activities.
• Support regulatory submission readiness and ensure TMF archival and inspection readiness.
• Partner with stakeholders and CROs to identify, mitigate, and resolve risks and escalated issues.
• Manage Data Management budgets, timelines, forecasting and performance metrics.
• Drive continuous improvement initiatives and adoption of technology within Clinical Data Management.
• Ensure compliance with ICH-GCP and applicable GxP requirements.

Required Skills

• Strong experience in Clinical Data Management
• Hands-on experience with clinical trial data review and database lock
• Strong CRO / vendor management and oversight experience
• Knowledge of CDISC standards and clinical data management processes
• Experience with EDC and clinical data collection technologies
• Understanding of ICH-GCP / GxP requirements
• Strong stakeholder management and cross-functional collaboration skills
• Excellent analytical, problem-solving and project management capabilities

Preferred Experience

Professionals with experience managing clinical data activities across global clinical development programs, working with CROs/third-party vendors, and collaborating with Clinical Operations, Biostatistics, Statistical Programming and other cross-functional teams are preferred.

INTERESTED CANDIDATES CAN SHARE THEIR UPDATED CVs AT:

shaifali@latinumhr.com