Clinical Data Manager

Description

bioMerieux is a global leader in the field of in vitro diagnostics, dedicated to improving public health and improving patient outcomes through innovative diagnostic solutions. . We are seeking a highly skilled and motivated Sr Clinical Trial Manager to join our team and lead clinical studies focused on cardiac biomarkers in an FDA-regulated environment.

Job Description:

We are seeking an experienced and highly motivated Clinical Data Manager to lead and perform Data Management (DM) activities of various Clinical Studies.

The Clinical Data Manager contributes to clinical studies 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 study data and performing data analysis at the service of the Clinical Affairs personnel in charge of the clinical study.

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

As Clinical Data Manager, you will lead data management activities along complex clinical studies 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 study
• Build and maintain eCRF in Medrio EDC based on the requirements from clinical study 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 study.
• Prepare data elements for clinical and analytical study reports and regulatory submissions.
• 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 study. 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.

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 in health industry (In Vitro Diagnostic is a plus).

Skills and Qualifications:

• Quality focus, analytical thinking/flexibility, teamwork, technical problem solving, ability to explain, good communication skills.
• Excellent oral and written communication and interpersonal skills, with the ability to work effectively with diverse teams.
• In-depth knowledge of Good Clinical Data Management Practices.
• Knowledge of relational data bases including SQL language, Cloud solution, Tableau (or other Business Intelligence software) and Python, is required.
• Advanced level user of Microsoft Excel.
• Basic statistical techniques.
• Knowledge of Electronic Data Capture (EDC system) is a real plus.