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Apsida Life Science have partnered with a leading global pharmaceutical company to present the following role:
Role: Trial Data Manager
Duration :12 months
Location: Switzerland
Competitive Salary Rate
Company Overview:
The client company is a biopharmaceutical company that focuses on developing and commercializing medicines, particularly in the cardiovascular field and immunological disorders.
Job Responsibilities
- Meets study timelines in terms of Data Management deliverables
- Ensures data handling consistency within allocated study(ies)
- Leads Data Management activities for assigned study
- Provides Data Management input to the development of the study protocol
- Organizes, monitors, and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
- Organizes, monitors, and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders Generates study metrics and status reports
- Represents Data Management at Clinical Trial Team (CTT) meetings
- Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners’ management)
- Prepares and archives Data Management study documentation
- Presents study related topics at CTT, Investigators and Monitors meetings
- Participates in development and review of policies, Standard Operating Procedures
- (SOPs), and associated documents for Data Management
- Represents Data Management in cross functional working groups related to the system / process
- Ensures Data Managers assigned to study have required training
- Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated, and provided as per agreed timelines
- Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handled according to protocol, applicable Quality System (QS) documents and GCP
Required Qualifications and Experience
- Recognized degree in life sciences, mathematics, statistics, informatics, or related disciplines
- At least 3 years’ experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical
- Data Management with good level of functional expertise in Data Management
- Good knowledge of international clinical research regulations and requirements (e.g., International
- Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report
- Form (CRF) design
If you are interested in learning more, please reach out to Mufaro Mpofu:
www.apsida.co.uk
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process
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