Job title: Senior Clinical Data Manager
Job description: 1. As Trial Data Manager (TDM) provides Data Management leadership across one or several trials. May have responsibility for a small program or indication within a large program
2. Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section
3. Develops and manages the Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials
4. Participates in the development of training materials for Investigator Meetings
5. Presents at Investigator Meetings (if needed)
6. Develops training materials and /or tools for conduct of the study
7. Disseminates study-level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM) 8. Begins to understand Study level metadata
9. Responsible for leading study start-up activities such as preparing the electronic Case Report Forms (eCRFs), Case Report Form Completion Guidelines (CCGs), DHPs, DRPs and performing User Acceptance Testing (UAT) (if required)
10. Obtains input from study team members on the design of clinical databases while ensuring data quality and compliance with SOPs
11. Responsible (and accountable) to ensure consistency of assigned trials with program level standards (DHPs, DRPs and eCRFs/CCGs)
12. Leads and participates in the ongoing review of all data generated from the clinical study including central and local lab data and coding
13. Leads and participates in the review of listings for quality, content, format and output
14. Responsible for ensuring that clinical data is validated according to the DHP and DRP and are ready for interim and final deliverables by providing clean and consistent data
15. Identifies trends in the data and possible solutions for efficiencies
16. Supports and assists junior staff for assigned trials (e.g. raising data issues for DRT attention)
17. Prepares final study documentation.
18. Leads and participates in the final review of all data generated from the clinical study
19. Leads and participates in the final review of listings for quality, content, format and output
20. Leads and participates in activities necessary for database finalization
21. Reports status and progress for assigned trials and is proactive to ensure smooth and successful timely snapshots and interim/final locks.
22. Ensures appropriate Novartis tracking systems are up to date and accurate Minimum requirements University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree Fluent English (oral and written).
Ideally 5 years experience in Drug Development with at least 4 years in Clinical Data Management,
Location: Hyderabad, Telangana – Andhra Pradesh
Job date: Fri, 05 Mar 2021 08:17:15 GMT
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