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TL-Clinical Data Management

TL-Clinical Data Management

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Cognizant

6 - 10 years

0 Lacs

kolkata west bengal

Posted:21 hours ago| Platform: Shine logo

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Skills Required

clinical data management uat data cleaning sae reconciliation mentoring issue resolution innovation process improvement audit therapeutic areas client communication study start up study conduct study closeout rave medidata veeva edc data management plan edit check creation data transfer specification creation query handling postproduction changes lab reconciliation ecoaepro reconciliation pkpd reconciliation dataset review study lock freezinglocking client facing role execute data management activities manual checks system checks update relevant trackers discrepancy query management database lock activities identify develop action plan archive support clinical trials technical oversight spotfire reporting tool third par

Work Mode

On-site

Job Type

Full Time

Job Description

As a Clinical Data Management professional with at least 6 years of experience, you should have exposure to Study Start up, Conduct, and Study Closeout phases. It is essential to have hands-on experience with Rave (Medidata) or Veeva EDC. Your key responsibilities will include: - Setting up DMP (Data Management Plan), creating Edit checks, Data Transfer specifications, and having knowledge of UAT. - Conducting Data Cleaning, managing Query Handling, Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, and Dataset review. - Freezing/Locking studies effectively during Study Lock phase. - Engaging in client-facing roles and providing mentoring as an added advantage. - Executing Data Management Activities such as Data Cleaning, Manual and System checks, Tracker updates, Discrepancy and query management, Issue resolution, and Database lock activities. - Participating in innovation and process improvement initiatives. - Identifying and developing action plans for activities not meeting client SLAs. - Archiving necessary information for audit purposes according to quality and security requirements. - Supporting multiple clinical trials across diverse therapeutic areas to successful conclusions and providing technical oversight when required. - Having hands-on experience in Study Setup and working exposure in RAVE/VEEVA EDC and knowledge of Spotfire reporting tool. - Handling third party data (Lab, PK, Image, etc.) and having experience in client communication. No additional details of the company are mentioned in the job description.,

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TL-Clinical Data Management