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

Clinical Data Management Cognizant

2.0 - 6.0 years

0 Lacs

maharashtra

On-site

You have 2 to 3 years of minimum Clinical Data Management experience. You must 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. In terms of setup, you should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, and some understanding of UAT (User Acceptance Testing) although it's not mandatory. Your experience in conducting tasks should include Data Cleaning, Query Handling, Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review, among others. You should be familiar with Study Lock activities such as Freezing/Locking and have good experience with Study lock procedures. Having a client-facing role and the ability to mentor others would be advantageous in this position. Your responsibilities will include executing Data Management Activities like Data Cleaning, Manual and System checks, updating relevant trackers, managing discrepancies and queries, resolving issues, and conducting Database lock activities. You will be expected to participate in innovation and process improvement initiatives, and to identify and develop action plans in coordination with the Team Lead for activities not meeting the client SLAs. Furthermore, you will need to archive all necessary information for audit purposes according to quality and security requirements to ensure reliable and timely retrieval of documentation and information. In addition, you will support multiple clinical trials across diverse therapeutic areas and provide technical oversight when required. Having hands-on experience in Study Setup and working exposure in RAVE/VEEVA EDC, as well as knowledge of the Spotfire reporting tool, will be beneficial. Experience in third-party data handling (Lab, PK, Image, etc.), client-facing roles, and effective client communication will also be valuable in this role.,

Posted 5 days ago

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