Clinical Database Manager

4 days ago

Gurgaon, Haryana, India ProcDNA Full time ₹ 8,00,000 - ₹ 12,00,000 per year

What we are looking for

We are seeking an experienced Clinical Data Manager (CDM) / Lead Clinical Data Manager to join our growing clinical data management team. The ideal candidate will have a strong background in end-to-end data management , EDC systems (preferably Medidata Rave, Veeva, InForm /CD or similar) , and experience leading or mentoring data management teams. This role will be office- based in Gurugram , with close collaboration with leadership and cross-functional teams to ensure data integrity, compliance, and quality throughout clinical studies. ​

What you'll do

  • Manage and oversee all aspects of clinical data management (CDM) activities for assigned clinical studies. ​
  • Develop and review Data Management Plans (DMPs) , CRF designs , edit checks , and data validation plans . ​
  • Ensure timely data cleaning, Query Management, Data review, Data/SAE Reconciliation, Database lock, and delivery of high-quality datasets . ​
  • Expertise in creating and maintaining the essential documents in eTMF or equivalent documents repositories in compliance with good documentation practices. ​
  • Collaborate closely with cross-functional teams, including database developer, Report Programmers, biostatistics and clinical operations. ​
  • Serve as a subject matter expert (SME) for assigned EDC systems (e.g., Medidata Rave, Veeva, InForm /CD or similar) . ​
  • Perform data review, discrepancy management, and validation per study timelines and SOPs. ​
  • Coordinate with vendors, CROs, and internal stakeholders for database development and testing. ​
  • Provide thought leadership and contribute to process improvements, automation, and standardization initiatives. ​
  • Mentor junior data managers and contribute to team development activities. ​

Must have

  • 8–12 years of relevant experience in Clinical Data Management in the pharmaceutical, CRO, or biotech industry. ​
  • Strong knowledge of EDC systems (Medidata Rave preferred). ​
  • Experience with metadata management, CRF annotation , and data validation . ​
  • Deep understanding of CDISC/CDASH standards , GCP , and clinical data workflows . ​
  • Excellent communication and interpersonal skills to collaborate with cross-functional teams. ​
  • Proven ability to handle multiple projects , meet deadlines, and maintain data quality. ​
  • Experience leading data management activities or mentoring team members is highly desirable.

Educational Background

  • Minimum qualification: Bachelor's degree in Life Sciences, Clinical Research, Microbiology, Biotechnology, or a related discipline. ​
  • Master's degree in Clinical Research, Life Sciences, Biomedical Science, or any other related scientific field is preferred.

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