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Clinical Database Manager

Clinical Database Manager

ConfidentialGurugram, Gurgaon / Gurugram, India
5 days ago
Job description

What We Are Looking For

We are seeking an experienced Clinical Data Manager (CDM) / Lead Clinical Data Manager to joinour growing clinical data management team. The ideal candidate will have a strong background inend-to-end data management, EDC systems (preferably Medidata Rave, Veeva, InForm / CD orsimilar), 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 ensuredata integrity, compliance, and quality throughout clinical studies.

What You'll Do

  • Manage and oversee all aspects of clinical data management (CDM) activities for assigned clinicalstudies.
  • Develop and review Data Management Plans (DMPs), CRF designs, edit checks, and datavalidation 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 documentsrepositories 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, andstandardization 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, orbiotech 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 (10+2+3) in Life Sciences, Clinical Research,Microbiology, Biotechnology, or a related discipline.
  • Master's degree in Clinical Research, Life Sciences, Biomedical Science, or any other relatedscientific field is preferred.
  • Skills : clinical data management,edc,subject matter experts

    Skills Required

    Metadata Management, cdisc, Gcp, Clinical Data Management, Data Review, Data Validation

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