Novartis is Hiring – CDM with 8+ years of experience.
Job Location : Hyderabad
Expert Clinical Data Managers (8+ years)
Program Clinical Data Managers (10+ Years)
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Clinical Data Manager is responsible for Provide timely and professional ongoing management of Data Management deliverables and 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.
Major Activities (Describe 8-12 main activities)
1. As Trial Data Manager (TDM) provides Data Management leadership across one or sev-eral trials. May have responsibility for a small program or indication within a large pro-gram
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 ensur-ing 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 out-put
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
23. Creates and maintains study specific project plans
24. Identifies timeline issues
25. Utilizes status and metric reports to identify training needs and issues with investigator sites
26. Is familiar with several types of 3rd party data
27. Maintains effective working relationships with Contract Research Organization (CRO) and other vendors as required
28. Able to propose solutions to resolve issues which may arise when handling 3rd party data from non-standard providers
29. Possess an understanding of regulatory topics and sponsor obligations as related to CRO and 3rd party providers. Able to represent DM in study level inspections
30. Gives input into Requests for Proposals (RFPs) and Study Specification Worksheets (SSWs) and evaluates proposals from CROs and other vendors
31. Able to provide effective DM input in process improvement efforts to systematically resolve issues that occur on outsourced trials
32. Ensure 3rd Party and Serious Adverse Event (SAE) reconciliation activities are performed in a timely manner and according to SOPs and Working Practices (WPs)
33. Acts as subject matter expert as assigned
34. Mentors and trains new colleagues and/or other team members as assigned
35. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Analytics & Business Intelligence
Role Category:Analytics & BI
Clinical Data Management Major Activities cdm data validation clinical data validation clinical cdm
Desired Candidate Profile:
Please refer to the Job description above
Novartis Healthcare Pvt. Ltd.
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 us one of the most rewarding employers in our field.