SME-Clinical Data Management Cognizant
Cognizant
Office Location
Full Time
Experience: 4 - 4 years required
Pay:
Salary Information not included
Type: Full Time
Location: Maharashtra
Skills: Clinical Data Management, UAT, Data Cleaning, SAE reconciliation, Mentoring, Innovation, Process Improvement, 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, Identify, develop action plan, Archive, Quality, security requirements, Support multiple clinical trials, Study Setup, RAVEVEEVA EDC, Spotfire reporting tool, Third party data handling
About Cognizant
Cognizant is a multinational information technology services and consulting firm headquartered in the United States. Its headquarters are located in Teaneck, New Jersey, in the United States. Cognizant is listed on the NASDAQ-100 under the symbol CTSH.
Job Description
JD CDM: 4 - 6 yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have: Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc. Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication,