Clinical Data Manager

Description

bioMérieux 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 :

Skills and Qualifications :

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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 , or by dialing 711 for access to Telecommunications Relay Services (TRS).