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Manager of Clinical Affairs Data Management

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Clinical Affairs

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

Position Summary:

As a Manager of Clinical Affairs Data Management, you will report into Clinical Affairs (CA) and be based in our St. Louis office. You will be in charge of a global Data Management team of Data Managers, including 5 US-based and 6 France-based team members (including contractors). The Data Management team is accountable for the development of clinical databases of our IVD clinical performance studies, and more precisely for setting-up all the data workflow including the verification and validation of any tools embedded in the process. Ultimately accountable for the data integrity, the DM team also contributes to the data consolidation along with clinical studies ultimately leading to a frozen dataset transferred to Bioscience for statistical analysis purposes.

 

Primary Duties:

  • You will be accountable for the Data Management processes and from this perspective, for the good execution of clinical trials according to Regulatory and Quality rules.  
  • You will guarantee DM deliverables on time, within budget, and with a high degree of customer satisfaction. For this, you will be operationally supporting the Data Management staff conducting clinical trials (phases of database design/workflow set-up, data monitoring preparation and execution, in multiple trial sites at a global level)
  • You will be working in close collaboration with other CA functions (Clinical Scientists, internal CA labs) management to achieve alignment in regards to the projects roadmaps, budget preparation, timelines and resource assignment, as well as other CA department priorities.
  • You will be leading the group with a thorough understanding of the capabilities and characteristics of personnel and the ability to maximize the unique contribution of each individual, with a continuous development of people, by training, mentoring and assuring the integrity of the performance management process and individual development/training plans.
  • You will be driving Data Management process improvement initiatives (or any other transversal projects at the service of CA), within CA or across other functions, inside the company.

 

Education and Experience Required:

  • Ph.D. or MS or Bachelor in a bioinformatic field with clinical emphasis or expertise
  • 5+ years of industry experience, 2 of which in IVD or pharmaceutical/health industry.
  • Management experience or willingness to evolve towards a management role, providing a strong background in Data Management

 

Knowledge, Skills and Abilities:

  • Experience in clinical trial management preferred.
  • Problem solving/judgment; Relationship building; Developing Others; Strong verbal and written communication skills; Establishing and sharing knowledge; Innovation; Multicultural experience
  • Regular trips to France to anticipate (once a quarter)
  • English mandatory / French ideal

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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