Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Eurofins Technologies is a new International Business Line (IBL) within the Eurofins Group focused on the development, manufacturing and marketing of bioanalytical technologies and diagnostic test kits in particular. The business if primarily focused on solutions in Food Safety and Environmental Safety but has recently expanded into Animal Health and Clinical Diagnostics. Eurofins Technologies serves both external customers (industrial laboratories, governmental laboratories, service laboratories) as well as customers within the Eurofins Group.

• Main point of client contact and study team for all DM related matters
• Execute all DM start-up activities, including the development and maintenance of
  • eCRFs and eCRF specifications
  • Edit check and custom listing specifications
  • Completion Guidelines
• Participate to the design of the CRF
• Develop test scripts and execution logs for User Acceptance Testing (UAT), issue logs, UAT summary report.
• Organize and actively participate in CRF review meetings with the client when needed
• Perform training on study trial for EDC and create user guides if needed
• Perform comprehensive hands-on data review of all subject data through query management and/or manual review.
• Analyzes study metrics to continually assess both data quality and study progress
• Track and provide project status updates to project managers for monthly project team meetings
• Develop Data Transfer Agreements between external data vendors and/or core labs
• Reconcile electronic data transfers from vendor to vendor
• Manage and prioritize project deliverables per study timelines
• Reconcile SAEs  when needed
• Work closely with CRA's to address any negative data trends/issues specifically ahead of site visits
• Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review
• Moderate (blind) data review meeting with statistician
• Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
• Participate in the review and development of Quality documents (SOP and working practices)
• Archive study databases and related documents.

• Bachelor's degree required / Master's degree preferred
• Performs project specific task and duties with minimal guidance
• Follows established procedures
• 3 to 5 years relevant data management experience in the CRO/pharmaceutical industry required
• EDC experience required
• Applicable knowledge working with other clinical databases such as SAS.
• Demonstrates knowledge of GCPs and protocol
• Strong comprehension and logic skills
• Strong time management and prioritization skills to meet deadlines among multiple projects
• Strong communication skills: verbal/written

PERSONAL CHARACTERISTICS

Eurofins has a culture of high professional standards, with strong processes, and an eye for details. Candidates will need to be fully aligned with this culture, which implies a structured and analytical approach, pragmatism, and modesty.

EVOLUTION:

In a fast growing group, successful leaders are frequently being offered increased areas of responsibility (subject to geographic mobility).

Gender : No Preference.