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Senior Clinical Data Associate

Prorelix Research
ProRelix Research
5-6 years
preferred by company
Pune, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Job Title: Senior Clinical Data Associate

Location: Pune, Maharashtra, India
Job Type: Full-Time
Experience Required: 5–6 Years (Freshers are not eligible)
Industry: Clinical Data Management / Clinical Research / Pharmaceuticals / Biotechnology / Healthcare
Work Model: On-site / Hybrid / As per company policy

About the Role
We are hiring an experienced Senior Clinical Data Associate to join a high-performing clinical data management team in Pune, India. This role is ideal for skilled clinical data professionals with strong expertise in clinical trial data handling, data quality review, database management support, and regulatory compliance within the pharmaceutical, biotechnology, or clinical research industry.

The ideal candidate will play a key role in ensuring the accuracy, integrity, and completeness of clinical trial data while supporting efficient study execution and compliance with global clinical research standards.

Key Responsibilities

Clinical Data Management & Data Review

  • Manage and review clinical trial data to ensure accuracy, consistency, and completeness across assigned studies.
  • Perform ongoing data cleaning, discrepancy management, and data validation activities.
  • Review case report forms (CRFs/eCRFs) and identify missing, inconsistent, or inaccurate data entries.
  • Generate, track, and resolve data queries in collaboration with study teams and research sites.

Database Support & Clinical Systems Coordination

  • Support clinical database build review, user acceptance testing (UAT), and data validation processes.
  • Collaborate with data management teams to maintain high-quality clinical databases and data standards.
  • Ensure proper handling of clinical data according to study protocols, database specifications, and SOPs.
  • Assist with data transfer reviews, reconciliation activities, and database lock preparation.

Quality Assurance & Regulatory Compliance

  • Ensure compliance with ICH-GCP guidelines, CDISC standards, SOPs, and regulatory requirements.
  • Support audit readiness and documentation quality reviews for assigned studies.
  • Maintain accurate documentation for data management activities and study records.
  • Contribute to risk identification and data quality improvement initiatives.

Cross-Functional Collaboration

  • Work closely with clinical operations, biostatistics, programming, medical monitoring, pharmacovigilance, and project teams.
  • Support issue resolution related to data discrepancies, timelines, and operational deliverables.
  • Participate in study review meetings and provide data status updates to stakeholders.

Process Improvement & Mentorship

  • Support process optimization initiatives to improve clinical data workflows and operational efficiency.
  • Guide junior team members on data review best practices, compliance expectations, and documentation quality.
  • Share knowledge and contribute to continuous improvement across clinical data management operations.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Computer Science, or a related field.
  • 5–6 years of relevant experience in clinical data management, clinical data review, or pharmaceutical research operations.
  • Strong understanding of clinical trial data management processes and regulatory requirements.
  • Experience with clinical data management systems, EDC platforms, and database workflows.
  • Familiarity with CDISC, ICH-GCP, MedDRA, WHO Drug coding, and clinical data standards is preferred.
  • Strong analytical thinking, documentation accuracy, and problem-solving skills.
  • Excellent communication and stakeholder coordination abilities.