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Senior Clinical Data Co-Ordinator

3+ years
₹8.5 LPA – ₹12 LPA
10 July 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Data Coordinator
Location: [Not Specified]
Experience Required: Prior experience in Clinical Data Management is required
Job Type: Full-Time


Job Description:
We are currently seeking a Senior Clinical Data Coordinator to serve as the primary point of contact for data management activities across clinical studies. The ideal candidate will be responsible for managing the end-to-end clinical data lifecycle, ensuring the integrity, accuracy, and timeliness of clinical trial data in compliance with sponsor and regulatory requirements.


Key Responsibilities:

Study Oversight & Coordination:

  • Act as the primary data management contact for assigned clinical studies.

  • Oversee and coordinate all delegated tasks across study team members.

  • Provide training and mentoring to new data management personnel, site staff, and sponsor teams.

Data Management Planning:

  • Author and review the Data Management Plan (DMP).

  • Design and review Case Report Forms (CRFs/eCRFs) for accuracy and compliance.

  • Participate in database design, including User Acceptance Testing (UAT).

Data Review & Cleaning:

  • Perform comprehensive data review and validation, raising and resolving data queries.

  • Coordinate with clinical CRO, sponsor, and investigative sites to manage data discrepancies.

  • Address medical coding discrepancies for adverse events, medical history, and medications.

Edit Checks & Database Integrity:

  • Develop and implement edit check specifications for assigned studies.

  • Lead initiatives for developing standard integrity checks across therapeutic modules.

  • Specify and review edit check logic and parameters to ensure robust database performance.

Quality Assurance & Reporting:

  • Collaborate with Quality Assurance teams for data audits and process reviews.

  • Generate and distribute real-time study monitoring reports to internal and sponsor teams.

  • Ensure all activities are compliant with SOPs, GCP, and regulatory guidelines.

Documentation & Archiving:

  • Maintain accurate data management documentation throughout the trial lifecycle.

  • Support corporate archiving processes for clinical data materials.

Recruitment & Training:

  • Assist with recruitment by interviewing and shortlisting data management candidates.

  • Deliver internal and external training on data entry systems and review workflows.


Desirable Skills and Experience:

  • Proven experience in Clinical Data Management across various phases of trials.

  • Hands-on expertise with eCRF systems, edit checks, data queries, and medical coding.

  • Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle InForm).

  • Strong understanding of GCP, CDISC, ICH guidelines, and data privacy regulations.

  • Excellent communication, coordination, and problem-solving skills.

  • Detail-oriented with strong documentation and reporting capabilities.

  • Leadership qualities to guide study teams and mentor new hires.


Estimated Salary: ₹8.5 LPA – ₹12 LPA (based on experience and tools proficiency)