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Clinical Affairs Data Manager

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

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Benefits at bioMerieux:

Low-cost medical, dental, and vision benefits starting day one
11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10000 per calendar year
Onsite cafeteria with daily food stipend
 

Position Summary:

The Clinical Data Management Specialist contributes to clinical trials (CT) through leading Data Management (DM) activities such as : defining the entire data workflow, building and maintaining clinical data bases, training end users, collecting, handling and storing clinical trial data and ensuring their quality and integrity at a global level following applicable procedures and regulation. He/She works closely and independently with both internal and external clinical trials partners such as Clinical Scientists, Biostatisticians, and clinical sites personnel.

 

 

Main Accountabilities: 

Lead and/or coordinate complex clinical trials as needed

  • Attend CT kick off and is a key actor of the CA element team. Provides data management inputs for CT protocol writing.
  • Initiate data management activities for each project : share proposal for future data bases design, highlight issues and specific needs. Ensure that timelines for data management activities is appropriate for CT.
  • Build and maintain data bases based on the requirements from CT protocol. Follow appropriate procedures to ensure that data bases are well validated and meet CT needs.
  • Complete the monitoring plan with CS and Biostatisticians based on the monitoring strategy. Develop programs, customized reports or equivalent to cover monitoring needs along the CT.
  • Train data bases end users : prepare the training support and ensure the training is delivered accordingly before CT start. Ensure good traceability for the training.
  • Manage data reviews and queries along the CT. Prepare and communicate reporting for CA element team members based on monitoring strategy. Including performing intermediate analyses as needed.
  • Organize closure activities linked to data management following applicable procedures and prepare data bases for future analysis as needed. Develop and update data management training modules. Train CA new arrivals at a global level.
  • Contribute to develop trainee(s) and apprentice(s) in Data Management.
  • Assist Management for continuous improvement initiatives and special projects. Translate tools enhancements, new processes in operational guidelines and training support and train end users accordingly. Ensure follow-up/maintenance for each enhancement. Share with key partners such as CS, Biomaths.

 

Studies-Experience:

  • Bachelor's Degree required preferably in Data Management/Bioinformatics or equivalent, with a minimum of 3+ years post degree relevant work experience preferred.

 

Skills and Qualifications:

  • Analytical thinking/flexibility, team work, technical problem solving, ability to explain, quality focus, good communication skills.
  • Knowledge of Electronic Data Capture (EDC system), programming language (e.g. SAS…), Pack Office is needed.
  • Knowledge of Relational data bases including knowledge of SQL language, Cloud solution, Tableau, and Python is a plus.
  • Ability to Train and educate
  • Excellent communication ability both, written & verbal
  • Excellent organization skills.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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