Senior Manager EDC Development

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager EDC Development in India.

This role is a key leadership position within clinical data systems, responsible for driving the design, development, and delivery of high-quality Electronic Data Capture (EDC) solutions across global clinical trial programs. You will oversee end-to-end EDC database development and user acceptance testing (UAT), ensuring compliance, consistency, and operational excellence across all systems. The position requires strong leadership in managing cross-functional teams, including managers and specialists, while coordinating global resources and vendor partnerships. You will play a critical role in standardizing processes, improving system quality, and introducing innovation in clinical data technologies. Working in a highly regulated environment, you will ensure adherence to global standards while driving continuous improvement and scalability. This is a high-impact role where your expertise directly supports the reliability and integrity of clinical research data.

• Lead and develop teams of managers and specialists across EDC Development, UAT, and Quality Control functions, including performance management and career growth.
• Oversee resource planning, workload distribution, and capacity management across global clinical trial portfolios.
• Drive end-to-end EDC database development including eCRF design, database build, edit check programming, and post-production updates.
• Manage UAT planning and execution, including defect resolution, testing validation, and release readiness assessments.
• Establish and enforce UAT standards, templates, and quality frameworks to ensure consistency across systems and vendors.
• Partner with CROs and cross-functional stakeholders to ensure alignment on EDC strategy and delivery quality.
• Lead innovation initiatives by evaluating and implementing new EDC technologies, tools, and automation solutions.
• Develop and maintain SOPs, governance models, and continuous improvement processes across EDC and UAT functions.
• Act as escalation point for complex technical, operational, and stakeholder management issues.

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Requirements:

• Bachelor’s degree in mathematics, science, information systems, or a related field (advanced degree preferred).
• 8+ years of experience in biotechnology, pharmaceutical, or healthcare industries.
• At least 4+ years of hands-on EDC development experience in regulated environments.
• Minimum 3+ years of people management experience leading technical or operational teams.
• Strong expertise in Medidata Rave, including database design, edit check programming, and administration.
• Deep understanding of UAT methodologies, QC processes, and clinical data standards.
• Knowledge of regulatory frameworks such as 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Proven experience managing CRO/vendor relationships and ensuring high-quality deliverables.
• Strong leadership, strategic thinking, and stakeholder management skills in matrix environments.
• Ability to influence senior stakeholders and drive cross-functional alignment.
• Exposure to tools such as Medidata Builder, TrialGrid, or programming languages (e.g., C#) is a plus.

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Benefits:

• Competitive compensation aligned with senior leadership responsibilities.
• Comprehensive health, wellness, and insurance coverage (medical, dental, vision, life, and disability where applicable).
• Annual performance-based incentives and equity/bonus programs (based on eligibility).
• Retirement and savings programs (varies by location).
• Paid time off including vacation, parental leave, and other applicable leave programs.
• Career development opportunities in global clinical data and research environments.
• Exposure to cutting-edge clinical data technologies and innovation initiatives.
• Inclusive, collaborative workplace with strong focus on scientific excellence and impact.