Associate Clinical Database Validation Manager | Full-Time | Bangalore / Kochi, India
Experience Required: 6+ years (including 4–6 years in Clinical Database Testing)
Job Description:
We are seeking an experienced Associate Clinical Database Validation Manager to lead end-to-end database validation and testing activities for clinical trials. This role is responsible for ensuring high-quality, compliant clinical databases through effective project management, team leadership, and adherence to regulatory standards. The ideal candidate will bring strong expertise in CDMS platforms, validation processes, and cross-functional collaboration.
Key Responsibilities:
Manage end-to-end delivery of database testing and validation services for single or multiple clinical projects, ensuring quality, timelines, and budget adherence.
Lead project planning, execution, and close-out activities, including resource allocation, risk management, and milestone tracking.
Develop and oversee Edit Check Test Plans and test cases, ensuring comprehensive validation coverage.
Conduct and supervise testing activities, including eCRF validation, Time & Events QC, and system configuration checks (roles, permissions, system settings).
Review and provide input on Edit Specifications, ASB documents, and testing outputs, escalating issues where necessary.
Track and document validation activities, including version control and testing documentation within eDMSF systems.
Collaborate with programmers, data teams, and internal stakeholders to resolve testing issues and improve processes.
Provide regular project status updates and ensure timely resolution of compliance and quality issues.
Serve as Subject Matter Expert (SME) for database validation and testing processes.
Train, mentor, and guide testing team members to enhance performance and technical expertise.
Implement quality management plans, identify root causes of issues, and drive continuous process improvements.
Manage project financials, monitor budgets, and highlight out-of-scope activities.
Act as the primary point of contact for internal stakeholders on validation deliverables and timelines.
Ensure compliance with Good Clinical Practice (GCP), regulatory guidelines, SOPs, and internal policies.
Qualifications & Experience:
Bachelor’s degree in Science, Computer Science, Information Technology, or related field.
Minimum 6+ years of total experience, including 4–6 years in clinical database testing and validation within CDMS platforms.
Strong understanding of clinical trial processes, database design, and validation methodologies.
Experience with eCRF design, edit checks, and testing lifecycle management.
Proven project management, leadership, and stakeholder management skills.
Strong analytical, problem-solving, and organizational abilities.
Excellent communication and interpersonal skills with the ability to manage cross-functional teams.
Location: Bangalore or Kochi, India
Why Join Us:
Work on global clinical trials with advanced database and validation technologies.
Collaborate with cross-functional teams in a fast-paced, innovation-driven environment.
Gain leadership exposure and career growth opportunities in clinical data management.
Be part of a quality-focused organization committed to regulatory excellence and continuous improvement.
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