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SPE-Clinical Data Management

SPE-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

2 - 6 years

0 Lacs

maharashtra

Posted:4 days 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 client communication study start up 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 system checks discrepancy query management database lock activities identify develop action plan archive support clinical trials technical oversight spotfire reporting tool third party data handling

Work Mode

On-site

Job Type

Full Time

Job Description

You should have a minimum of 2 to 3 years of Clinical Data Management experience. It is essential to have exposure to Study Start-up, Conduct, and Study Closeout. If you do not have experience in all three phases, you should have good exposure to a minimum of two phases. Hands-on experience with Rave (Medidata) or Veeva EDC is a must. You must possess the following skills: - Setup experience with knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and UAT knowledge (not mandatory). - Conduct experience including Data Cleaning (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, and Dataset review. - Study Lock experience with expertise in Freezing/Locking. Having a client-facing role and mentoring experience are considered added advantages. Your responsibilities will include: 1. Executing Data Management Activities such as Data Cleaning, Manual and System checks, Updating relevant trackers, Discrepancy and query management, Issue resolution, and Database lock activities. 2. Participating in innovation and process improvement initiatives. 3. Identifying and developing action plans in coordination with the TL for activities not meeting the client SLAs. 4. Archiving all necessary information for audit purposes according to quality and security requirements. 5. Supporting multiple clinical trials across diverse therapeutic areas and providing technical oversight when required. 6. Having hands-on experience in Study Setup. 7. Working exposure in RAVE/VEEVA EDC and knowledge of Spotfire reporting tool. 8. Experience in third-party data handling (Lab, PK, Image, etc.) and client-facing role with experience in client communication.,

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SPE-Clinical Data Management