Senior Director – Clinical Data Management (CDM)
Company: [Your Company Name / Global Biopharmaceutical Organization]
Business Unit: Clinical Development / Data Management
Location: India – Open to Hybrid/Remote (Gurugram / Mumbai Preferred)
Job Type: Full-Time
Experience Required: 12–15 Years in Clinical Data Management or related fields
Job Grade: Senior Leadership
Job Overview
We are seeking an accomplished Senior Director – Clinical Data Management (CDM) to lead global clinical data strategies, drive high-quality clinical trial data collection, and ensure regulatory compliance across multiple therapeutic areas. The ideal candidate will have extensive experience managing complex clinical trials, CDM teams, and data systems in a pharmaceutical, biotechnology, or CRO environment.
As a key member of the Clinical Development leadership team, you will oversee end-to-end CDM operations, implement innovative data solutions, and ensure data integrity and submission readiness for global regulatory authorities.
Key Responsibilities
Leadership & Strategy
Lead and manage a high-performing global CDM team, fostering collaboration, continuous improvement, and professional development
Develop and implement clinical data management strategies aligned with organizational goals and regulatory expectations
Establish governance frameworks and data standards for multiple ongoing and upcoming clinical trials
Clinical Data Operations
Oversee end-to-end clinical data management processes, including database design, validation, EDC management, CRF development, data cleaning, and reconciliation
Ensure timely delivery of high-quality clinical trial data for regulatory submissions (NDA, BLA, IND, ANDA)
Implement risk-based monitoring, data quality metrics, and CDM KPIs to optimize study efficiency and quality
Technology & Innovation
Drive adoption of innovative CDM tools, AI/ML platforms, and automation to improve data accuracy and operational efficiency
Evaluate and manage vendor partnerships and CDM outsourcing strategies to support global study operations
Regulatory & Compliance Oversight
Ensure all CDM operations comply with ICH-GCP guidelines, regulatory standards, and SOPs
Provide oversight for regulatory submission packages and respond to audit and inspection requirements
Collaborate with Clinical Operations, Biostatistics, Medical Affairs, and Regulatory teams to ensure alignment and compliance
Stakeholder Collaboration
Act as a key interface between internal leadership, external CRO partners, and global regulatory authorities
Provide strategic guidance on clinical data trends, regulatory expectations, and operational efficiencies
Job Requirements
Educational Qualification
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline
Advanced degrees (MS/PharmD/PhD) preferred
Experience
12–15 years of experience in Clinical Data Management, with at least 5 years in senior leadership roles
Proven track record in global clinical trial data management, regulatory submissions, and CDM team leadership
Skills & Competencies
In-depth knowledge of EDC systems (Medidata RAVE, Veeva, Oracle Clinical, etc.) and clinical trial processes
Strong understanding of CDISC standards (SDTM, ADaM), data validation, and risk-based monitoring
Excellent leadership, organizational, and strategic planning skills
Strong analytical, problem-solving, and communication skills, with ability to influence cross-functional teams
Demonstrated experience in vendor management, budgeting, and resource planning
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