Novartis CDM Jobs For Life Sciences at Global Drug Development Division
Novartis CDM Jobs For Life Sciences at Global Drug Development Division. BSc/MSc Life Science candidates apply online for a Senior Clinical Data Manager position that is available at Novartis. Novartis is hiring msc/bsc candidates, as per the details below in their Research & Development area:
Job Title: Senior Clinical Data Manager
Job ID: 288996BR
Division: Global Drug Development
Business Unit: GDO GDD
Employment Type: Full-time
Your key responsibilities:
Your responsibilities include, but not restricted to:
- 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
- Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section
- Develops and manages the Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials, Develops training materials and /or tools for the conduct of the study
- Participates in the development of training materials for Investigator Meetings and Presents at Investigator Meetings (if needed)
- Disseminates study-level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
- Begins to understand Study level metadata. 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)
- Obtains input from study team members on the design of clinical databases while ensuring data quality and compliance with SOPs
- Responsible (and accountable) to ensure consistency of assigned trials with program-level standards (DHPs, DRPs and eCRFs/CCGs)
- Leads and participates in the ongoing review of all data generated from the clinical study including central and local lab data and coding
- 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. Identifies trends in the data and possible solutions for efficiencies. Supports and assists junior staff for assigned trials (e.g. raising data issues for DRT attention). Prepares final study documentation.
- Leads and participates in the final review of all data generated from the clinical study, listings for quality, content, format and output, activities necessary for database finalization
Reports status and progress for assigned trials and is proactive to ensure smooth and successful timely snapshots and interim/final locks. Ensures appropriate Novartis tracking systems are up to date and accurate.
Minimum requirements:
What you’ll bring to the role:
- University or college degree in lifescience, 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
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