Senior Clinical Data Standards Lead

Daiichi Sankyo Co.; France; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Daiichi Sankyo is seeking a Manager, Clinical Data Standards to lead the development, maintenance, and implementation of global data standards supporting regulatory submissions across therapeutic areas. The role collaborates with cross-functional teams to optimize data collection, mapping to CDISC/SDTM, and regulatory alignment.

The ideal candidate has strong SDTM expertise, hands-on data standards experience, and the ability to deliver in a fast-paced R&D environment across global locations

Qualifications

• Bachelor’s degree in life sciences or a related field.
• 5+ years of clinical data management experience in a pharmaceutical, medical device, or CRO environment.
• 2+ years of experience in clinical data standards.
• Experience in oncology, immunology, or other complex disease areas preferred.
• Working knowledge of CDASH, CDISC, and SDTM standards.
• Knowledge of data models, metadata, structures, and definitions.
• Strong analytical thinking and problem-solving skills.
• High attention to detail and quality.
• Ability to work effectively across cross-functional and multicultural teams.

Responsabilités

• Lead implementation of clinical data collection standards across programs and therapeutic areas.
• Partner with internal teams and external vendors/labs to ensure consistent data acquisition, processing, and reporting.
• Act as the subject matter expert for clinical data standards and support alignment with regulatory and internal requirements.
• Develop, maintain, and improve clinical data standards, governance documents, templates, and procedures.
• Provide technical guidance on new and existing data standards for assigned programs and studies.
• Support standardization of diverse data types, including biomarker and medical device data, in line with CDISC/SDTM standards.
• Review change requests, protocols, libraries, and standards packages to improve standardization of eCRFs, checks, and reporting.
• Lead or participate in standards governance meetings and ensure timely review and decision-making.
• Train and advise study teams on data standards to ensure consistent understanding and implementation.
• Monitor industry trends, emerging technologies, and regulatory updates to enhance data standards strategy and operations.

Connaissances

Analytical thinking

Problem-solving

Attention to detail

Cross-functional teamwork

Collaboration

Formation

Bachelor’s degree in life sciences

Outils

Medidata Rave

MDR

CDR

Description du poste

Daiichi Sankyo is seeking a Manager, Clinical Data Standards to lead the development, maintenance, and implementation of global data standards supporting regulatory submissions across therapeutic areas. The role collaborates with cross-functional teams to optimize data collection, mapping to CDISC/SDTM, and regulatory alignment.

The ideal candidate has strong SDTM expertise, hands-on data standards experience, and the ability to deliver in a fast-paced R&D environment across global locations