Clinical Data Management Specialist

Compensation

: $87,910.00 - $126,540.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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A strong Scientific and technological pioneering spirit drives bioM rieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioM rieux commitment to public health.

bioM rieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.

We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.
The Clinical Data Management Specialist contributes to clinical trials (CT) trough leading Data Management (DM) activities such as : 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 SAS 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.
  • 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.
  • Provides support for Data Management tools improvement and development as well as tools maintenance .
Studies-Experience:

Bachelor preferred in Data Management/Bioinformatics or equivalent, with a minimum of 3-5 post degree relevant experience preferred.

Skills and Qualifications:

Analytical thinking/flexibility, team work, technical problem solving, ability to explain, quality focus, good communication skills. Relational data bases including knowledge of SQL language, SAS, Pack office.

Knowledge of Cloud solution is a plus..

Ability to Train and educate

Excellent communication ability both, written & verbal

Excellent organization skills.

bioM rieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.
Associated topics: data administrator, data analyst, data center, data integration, data manager, data scientist, erp, mongo database, sql, teradata * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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