Process Specialist-CDM/PV
- Cognizant
- 2 - 4 years
- Mumbai
- 8 months ago
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Job Description
Job Summary
Data Manager
Should have 3.5+ years of experience in CDM with exposure to any 2 phases from Start up, Conduct, Close out.Exposure to UAT, SAE Reconciliation, Archival and tools like Medi Data and RAVE.
Responsibilities
JD CDM:
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
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), Post Production 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.
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Data Science & AnalyticsRole Category: Business Intelligence & AnalyticsRole: Business AnalystEmployement Type: Full timeContact Details:
Company: CognizantLocation(s): Mumbai
Keyskills: data management production dmp lab data cleansing review oracle clinical clinical trials reporting sae reconciliation query handling medidata rave edc spotfire change uat clinical data management mentoring rave cdm reconciliation post production veeva clinical research slas
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