Manager, Clinical Data Standards (m/f/d)

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

Manager, Clinical Data Standards (m/f/d)

Job Title: Manager, Clinical Data Standards (m/f/d)
Job Requisition ID: 2215
Posting Start Date: 9/21/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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