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.
- Freezing/Locking, Should have good experience of Study lock