Reporting to the Clinical Affairs department, and based in our Saint Louis facilities, you will be part of a Data Management team of 4 Data Managers, corresponding to a subpart of an international Data Management group which includes also a 4 data managers team based in France (Marcy l'Etoile (near Lyon)).

The Data Management (DM) 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. The DM team also contributes to the data consolidation along with the clinical study ultimately leading to a frozen dataset transferred to Bioscience for statistical analysis purposes.

Position Summary:

The Sr. Data Manager 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, set up any processes to collecting, handling, storing clinical trial data at the service of the Clinical Affairs personnel in charge of the clinical trial contributing to guaranteeing their quality and integrity.

The Sr. Data Manager works closely and independently with both internal and external clinical trials partners such as Clinical Affairs personnel, Data Science and clinical site interfaces.

As a Sr. Data Manager, you will lead data management activities along complex clinical trials with respect to applicable regulatory and quality referential:

• Define the User Requirements Specifications with the Clinical Affairs personnel and Data Scientists in charge of the clinical trial
• Build and maintain eCRF in Medrio EDC based on the requirements from clinical trial protocol.
• Develop python (pandas) programs (AWS).
• Write/Execute appropriate Verification and Validation procedures to ensure the data flow is properly validated.
• Build in Tableau software some customized reports/dashboards to cover monitoring needs along the clinical trial.
• Organize closure activities linked to data management following applicable procedures as needed.

You will be a key actor of the clinical project team in charge of conducting the clinical trial. You will be providing inputs for CT protocol writing (data capture, retrieval and handling perspectives), sharing proposal for future EDC and data flow design as well as highlighting issues and specific needs.

The global DM team works in an agile mode (inspired from the Scrub methodology). In this context, daily discussions (15-30 minutes) at a global DM team level are in place to share about activities, workload and technical issues.

Finally, you will contribute to departmental projects for tools/processes' continuous improvement and life cycle management of the data management documentation.

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:

• Quality focus, analytical thinking/flexibility, teamwork, technical problem solving, ability to explain, good communication skills.
• Knowledge of a programming language and Pack Office is required.
• Knowledge of relational data bases including SQL language, Cloud solution, Tableau (or other Business Intelligence software) and Python, is required.
• Knowledge of Electronic Data Capture (EDC system) is a plus.
• Knowledge and experience of the scrum methodology is a real plus.