Senior Manager EDC Development
On-site · Hyderabad, Telangana, India
Job Summary
Senior Manager, EDC Development & UAT leads global EDC database development and UAT activities, ensuring high-quality, compliant EDC system delivery from design through release and post-production. Drives standardization, innovation, and continuous improvement across EDC processes, oversees a team of managers and specialists, ensures UAT planning and defect management, establishes standards and templates, and partners with CROs to align on strategy and quality results. Requires extensive Medidata Rave experience, strong regulatory knowledge (21 CFR Part 11, ICH-GCP, CDISC), and proven leadership in a matrix environment. On-site role at Hyderabad office.
Required Qualifications
- Bachelor’s degree in mathematics, science, information systems, or a related field
- Minimum of 8+ years of experience in biotechnology, pharmaceutical, or healthcare industry
- Minimum 4+ years of direct EDC development experience
- Minimum 3+ years of people management experience
- Experience handling CRO/vendor relationships and ensuring high-quality deliverables
- Proven leadership experience in a matrix environment
- Medidata Rave expertise including database design, edit check programming, and platform administration
- Knowledge of regulatory requirements including 21 CFR Part 11, ICH-GCP, and CDISC standards
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