Position is designated as a Sr CDM : 5 - 10 years (We are looking some one at Trail data Manager Level )
Roles and responsibilities :
Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.
1. Serve as Trial Data Manager for multiple trials and may act as a PDM for small study programs; Provide input on CTT(s)/GCT (s).
2. Assist Project Data Manager to ensure consistency of Protocols, Validation and Analysis Plans (VAPs) & eCRFs for all trials within assigned projects.
3. Responsible for contributing to protocols and preparing the eCRF ,CCG, VAP, da-tabase design testing (UAT), identifying errors and inconsistencies, freezing and locking database as appropriate).
4. May respond to Health Authority requests for data management issues.
5. Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s).
6. Provide input, review, and maintenance of global working practices and standards.
7. Contribute to the development of the local Data Management group through his/her leadership role within the group.
8. Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.
9. Ensure appropriate Novartis tracking systems are up to date and accurate.
10. Participate in clinical & non-clinical special projects.
11. Assist in coaching, training and mentoring of Data Management staff.Company Profile:
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