Senior Data Standard Expert (m/f), Lyon

Merck - avec plus de 300 ans de progrès et plus de 38000 employés dans le monde, se positionne en leader sur le marché Pharmaceutique, Chimique, et des Sciences de la vie. Avec passion, engagement et innovation, nous poursuivons un objectif commun : améliorer la qualité de vie. C'est pourquoi nous avons besoin de vous!

Your role

You will act as reference for Data Collection standards and support the development, maintenance, optimization, and implementation of General and Therapeutic data standards (Clinical Data Collection: CRF and external data sources using Metadata Repository) based on CDISC and industry standards. You will participate in the study protocol review and assess impact on Data Collection standards. You will lead discussions for new content of CRF and collaborate with internal/external stakeholders (e.g. Data Management, Stats/ Programming, PK/PD and Biomarker departments, etc.). Design and update data collection forms. Collaborate with the SDTM team, as well as engaging with cross functional teams on departments initiatives. You will lead process improvement initiatives. Prepare and communicate the standard libraries releases for cross functional teams and external partners and maintain the Standards company eDC library (incl Edit Checks and CRF CG).
Supports defining/maintaining a governance framework for data standards and change and contribute/lead the Governance and Advisory Boards.

Your profile

• BS and or MS with 10+ years in data management or standards experience.
• Proven experience in clinical study set-up, CRF design and Edit check programming.
• Proven experience in Data Standards Development and Governance
• Proven experience in development and implementation of Data Management functionalities, tools, workflows, and validation procedures
• Project leadership expertise
• Excellent Knowledge of eDC systems and MDR (Like Formedix)
• Excellent Knowledge of CRF industry standards and CDISC standards
• Excellent understanding of trial activities and drug development, sound understanding of the Global Clinical Development function, as well as understanding of the pharma ethical business and commercial environment