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Clinical Data Manager

TCS
2-8 years
INR 8 LPA – 18 LPA
Bangalore, Hyderabad, Mumbai, India
1 June 15, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Clinical Data Manager

Location: Bengaluru, Hyderabad, Pune, Mumbai, India
Employment Type: Full-Time

Job Summary

The Clinical Data Manager is responsible for overseeing clinical data management activities throughout the study lifecycle, ensuring the accuracy, consistency, integrity, and quality of clinical trial data. The role involves study conduct support, discrepancy management, data reconciliation, stakeholder coordination, and delivery of high-quality clinical data in compliance with regulatory requirements and study timelines.


Key Responsibilities

Clinical Data Management

  • Manage and support clinical data management activities across assigned clinical studies.

  • Ensure clinical trial data is complete, accurate, and compliant with study protocols and regulatory requirements.

  • Review and validate clinical data for consistency, integrity, and quality.

  • Support study conduct, database maintenance, and study closeout activities.

Discrepancy & Query Management

  • Identify, investigate, and resolve data discrepancies.

  • Raise, track, and manage system-generated and manual queries.

  • Collaborate with study sites and stakeholders to ensure timely query resolution.

  • Monitor data quality metrics and drive issue resolution.

Data Reconciliation

  • Perform and oversee reconciliation activities for:

    • Serious Adverse Events (SAE)

    • Interactive Web Response Systems (IWRS)

    • Central Laboratory Data

    • External Vendor Data

  • Ensure reconciliation activities are completed accurately and within timelines.

  • Investigate and resolve discrepancies between internal and external datasets.

Study Conduct & Oversight

  • Own assigned study conduct activities from study startup through database lock and closeout.

  • Monitor study progress and data quality throughout the clinical trial lifecycle.

  • Ensure adherence to project timelines, SOPs, and regulatory guidelines.

  • Support database lock activities and final data review processes.

Stakeholder Management

  • Act as the Single Point of Contact (SPOC) for study-related communications.

  • Collaborate with Clinical Operations, Biostatistics, Medical Monitoring, Pharmacovigilance, and external vendors.

  • Provide regular study updates and communicate risks, issues, and mitigation plans.

  • Facilitate cross-functional discussions to ensure project success.

Risk Management & Process Improvement

  • Proactively identify study risks and develop mitigation strategies.

  • Support continuous improvement initiatives within clinical data management processes.

  • Share best practices and lessons learned across teams.

  • Contribute to process standardization and operational excellence initiatives.

Quality & Compliance

  • Ensure compliance with GCP, ICH guidelines, SOPs, and applicable regulatory requirements.

  • Maintain audit-ready documentation and study records.

  • Support inspection readiness and quality assurance activities.

  • Ensure delivery of high-quality, error-free clinical data.


Required Qualifications

Education

  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Clinical Research, Biotechnology, Nursing, or a related scientific discipline.

Experience

  • 2–8 years of experience in Clinical Data Management, Clinical Research, or Clinical Operations.

  • Experience working in pharmaceutical, biotechnology, CRO, or healthcare research environments.

  • Experience managing study conduct activities and clinical databases.