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)
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