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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Clinical Data Manager
Job Description: Provide timely and professional ongoing management of clinical trial data with respect to cost, quality and timelines for assigned trials managed within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.
1. As Clinical Data Manager (CDM) provide data management input on Clinical Trial Teams. May have the role of TDM on small, low complexity trials
2. Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section
3. Gives input to Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials. Responsible for the development of these documents if assigned the role of Trial Data Manager (TDM)
4. Participates in the preparation of training materials for investigator meetings
5. Disseminates study-level information either to the TDM (if assigned to a trial as a Data Manager) or to the Clinical Trial Team (CTT) & Program Clinical Data Manager (PCDM) if assigned the role of TDM
6. Performs DM activities for start-up of a study including preparing the eCRF, CCGs, DHPs, DRPs and performing User Acceptance Testing (UAT) if required
7. Obtains input from study team members on the design of clinical databases while ensur-ing data quality and compliance with SOPs (if assigned the role of TDM)
8. Under supervision from PCDM (or delegate), ensures consistency of assigned trials with program level standards (DHPs, DRPs & eCRFs) Prepares final study documentation.
9. Performs ongoing review of all data generated from the clinical study including central and local lab data and coding
10. Interacts with the study team members to define the necessary listings needed to support data validation
11. Performs review of listings for quality, content, format and output
12. Identifies possible trends in data Leads and participates in the final review of all data generated from the clinical study
13. Participates in the preparation (if assigned as DM level) or prepare final study documentation
14. Performs final review of listings for quality, content, format and output
15. Performs activities necessary for database finalization and adhering to the timelines es-tablished by the study team
16. Verifies and tracks eCRF/CRF completion and provide data status updates
17. Ensures appropriate Novartis tracking systems are up to date and accurate
18. Actively participates at the study team level
19. Utilizes status and metric reports to identify training needs and issues with investigator sites
20. Gathers requirements for third party data
21. Maintains effective working relationships with Contract Research Organization (CRO) and other vendors as required
Candidate Profile: University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree Fluent English (oral and written). Ideally 3 years’ experience in Drug Development with at least 2 years in Clinical Data Management
Additional Information:
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 25th January, 2016
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Regards,
Deepak Kumar Bandari,
Pharm.D Intern,
Vaagdevi College of Pharmacy - India
Elsevier Student Ambassador - South Asia
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