Apsida Life Science
Clinical Data Manager
Apsida Life ScienceSwitzerland7 days ago
ContractResearch, Science

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:


[email protected]


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