Role : Clinical Data Management
EXP: 2-8 Years
Skills: Clinical Data Management, Study Conduct and Close Out,Discrepency Management, SAE Reconciliation
Location: Mumbai, Pune, Hyderabad, Bangalore
Responsibility / Expectations from the Role
1 Preparing eCRF specifications, Edit check specification and other study specific set up documents
2 Reviewing of Protocol Deviation Document and study protocol deviations.
3 Review and finalizing eCRF completion guidelines.
4 Review, update and/or approve study specifications.
5 Perform eCRF review and approve.
6 Create/Review Test Scripts for edit checks
7 Coordinate with study team for timelines and issues.
8 Create UAT test scripts.
9 Ensure quality for study deliverables.
10 Deployment Checklist completion
11 Reviewing UAT plan, UAT performance and UAT report by Clinical Data Manager.
12 Review and maintenance of DMP Metrics. Weekly status meetings
13 Identifying issues with validation procedures during study conduct and communicating findings to Operations manager and Client.
14 Communicating site data issues (dataflow, discrepancies, etc.) with Sites, monitors, colleagues and Client as necessary.
15 Supporting in execution of data listings programs and dataset reviews for patient data consistency, quality and completeness
16 Utilization of appropriate data management tools to monitor quality and timeliness of data flow for assigned sites
17 Identify/drive areas for process improvement for the project aligned.
18 Hands-on production work along with Clinical Data Managers as and when need arises.
Intrested candidates are requested share updated CV with below details on the mentioned mail id - s.laharika@tcs.com
Regards,
Samudrala Laharika
Sourcing Specialist
Corporate HR- Talent Acquisition Group
Mail to: s.laharika@tcs.com