Clinical Data Facilitator Job in Novo Nordisk India Private Limited
Clinical Data Facilitator
- Bengaluru, Bangalore Urban, Karnataka
- Not Disclosed
- Full-time
- Permanent
The Position As a Clinical Data Facilitator, you will be responsible for supporting end users and must act independently following the strategic objectives of the standard governance bodies and the company in general. Take ownership on trials assigned by project team to ensure standardization and to a large extent, be performed in accordance with SOPs, policies, and the Novo Nordisk Way. Responsible for site user access management on different DM systems (EDC and eCOA). Configuration settings in User Management tool (UMT). Perform compilation of sample (e)CRF and completed (e)CRFs, appendix of Clinical Trial Report (CTR) and Non-interventional Study Report (NSR) for clinical trial and archival in EDMS. Support (e)CRFs preparation for submission deliverables at the project level to make them eCTD compliant. Perform activities related to submission readiness of PDF files part of SDTM package (aCRF, cSDRG etc) Responsible for coordinating the changes in clinical system and interfaces (EDC, IWRS, ARGUS). Drive UAT process for Study build trials and handle trial related UAT documentation. Experience Masters / Bachelor s degree in Life Science or comparable degree in Computer science, Information Technology Clinical Information Management or equivalent qualifications. 2 plus years within clinical data management systems, experience in Project management, Vendor Management, System Management, or related areas. Knowledge of computer systems and IT. Excellent Communication and Presentations skills. Experience with project management Knowledge of GxP and guidelines within drug development. Lives up to NN values: accountable, ambitious, responsible, and engaged with stakeholders, open & honest and ready for change. Quality mind-set and strong analytical skills Ability to bridge between different functional areas
Fresher
2 - 4 Hires
