Manager, Clinical Data Standards

Location

Primary location: France

Second location: Germany

Purpose of the function

The Manager, Clinical Data Standards is responsible for leading the development, maintenance, and implementation of Global Clinical Data Standards to support high-quality regulatory submissions and the success of the Daiichi Sankyo R&D pipeline across therapeutic areas. The role partners with cross-functional stakeholders to optimize clinical data collection and ensure data standards and mapping align with CDISC and Health Authority requirements.

This position requires solid knowledge of diverse data types, EDC and non-EDC collection methods, and hands-on experience with industry standards such as Controlled Terminology, CDASH, SDTM, and ADaM. The successful candidate should be a self-starter, solution-oriented, and able to deliver results in a fast-paced environment. Strong expertise in clinical data standards, especially SDTM, as well as excellent communication, analytical, and interpersonal skills, are essential. The role also serves as a subject matter expert in clinical data standards for the development of clinical data collection tools.

Roles and Responsibilities

• 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.

Education & Experience

• 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 clinical trial systems such as Medidata Rave, MDR, and CDR.
• Strong understanding 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.