A job opening has arisen for a Trial Data Manager to join a growing biopharmaceutical organisation in Switzerland. This role will entail ensuring that Data Management (Biometry) activities adhere to the organisation's standards and applicable regulations.

Job Responsibilities:

• Meets study timelines in terms of Data Management deliverables.
• Ensures data handling consistency within allocated studies.
• Leads Data Management activities for assigned studies.
• Provides Data Management input to the development of the study protocol.
• Coordinates the development of the (e)CRF in line with company standards.
• Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmer(s) for development for the allocated studies.
• 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 stakeholders.
• Generates study metrics and status reports.
• Represents Data Management at Clinical Trial Team 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.
• Any other assigned duties.

Key Skills:

• Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study.
• Good organizational and presentation skills.
• Fluent in written and spoken English.

Requirements:

• 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 Conference on Harmonization - Good Clinical Practice (ICH/GCP)).
• Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form design.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

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