Data Manager (Expert in Programming & developing EDC systems)
IndiaFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 4–8 years of experience
- Required Skills
- Analytical SkillsProblem Solving
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, or a related scientific discipline.
- 4–8 years of experience in clinical data management within a pharmaceutical company, CRO, or similar regulated environment.
- Strong expertise in EDC systems, clinical database design, validation processes, and data cleaning activities.
- Solid understanding of clinical trial processes, data standards, and regulatory compliance requirements.
- Experience with SAS, edit checks, and data validation processes is highly desirable.
- Strong analytical mindset with excellent attention to detail and problem-solving skills.
- Ability to manage multiple studies simultaneously with minimal supervision.
- Effective communication skills and ability to work in cross-functional, international teams.
Responsibilities
- Support end-to-end clinical data management activities from study start-up through database lock, ensuring high-quality and compliant data delivery.
- Perform validation of EDC systems, edit checks, SAS programs, and related data management reports and outputs.
- Build, test, and maintain clinical databases, including user acceptance testing and specification development for EDC systems.
- Manage EDC user accounts and ensure proper system access and functionality across studies.
- Oversee data cleaning activities including query management, SAE reconciliation, lab data tracking, and vendor data reconciliation.
- Perform or support data entry, medical coding, and review of study data as required.
- Generate and review study metrics, identify risks or roadblocks, and escalate issues appropriately to ensure timely resolution.
- Support database close-out activities, including final reconciliations, query resolution, and study reporting for database lock.
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