Senior Clinical Data Manager

Job Description

268706BR Senior Clinical Data Manager Job Description Your responsibilities: Your responsibilities include, but are not limited to: 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 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 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 4 years experience in Drug Development with at least 3 years in Clinical Data Management Why consider Novartis750 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s livesWe believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Division Global Drug Development Business Unit GDO GDD Country India Work Location Hyderabad, AP Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area Research & Development Job Type Full Time Employment Type Regular,

Keyskills :
programmingatabaseadministrationcasereportformsclinicaldatamanagementcustomerrelationsdataqualitydatamanagementuseracceptancetestingstatementsofworksowdatavalidationglobaldrugdevelopment