Clinical Data Manager

Job Description

TCS is hiring for Clinical Data Management role
Location -Hyderabad/Bangalore

Preparing eCRF specifications, Edit check specifications and other study specific set up documents

Reviewing Protocol Deviation Document and study protocol deviations.

Review and finalizing eCRF completion guidelines.

Review, update and/or approve study specifications.

Perform eCRF review and approval.

Create/Review Test Scripts for edit checks

Coordinate with study team for timelines and issues.

Create UAT test scripts.

Ensure quality for study deliverables.

Deployment Checklist completion:

Reviewing UAT plan, UAT performance and UAT report by Clinical Data Manager.

Review and maintenance of DMP Metrics. Weekly status meetings

Identifying issues with validation procedures during study conduct and communicating findings to Operations manager and Client.

Communicating site data issues (dataflow, discrepancies, etc.) with Sites, monitors, colleagues and Client as necessary.

Supporting in execution of data listings programs and dataset reviews for patient data consistency, quality and completeness

Utilization of appropriate data management tools to monitor quality and timeliness of data flow for assigned sites

Identify/drive areas for process improvement for the project aligned.

Hands-on production work along with Clinical Data Managers as and when need arises.

Desired Candidate Profile
Qualifications :BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), M.SC., MASTER OF PHARMACY