The Clinical Data Standards Manager (CDSM) is a subject matter expert in the field of clinical data standards as defined by regulatory authorities and industry bodies (e.g., CDISC) and required for clinical data submissions.

This role supports Clinical Data Managers (CDM), Data Management Leads (DML), and the broader Clinical Trial Team (CTT) in ensuring that clinical data is accurate, consistent, and of sufficient quality for analysis and reporting, while fully compliant with local and global regulations.

 Main activities are:

  • Lead cross-functional efforts to develop data standards-driven processes and solutions that meet scientific objectives while ensuring quality, consistency, and compliance with CDISC standards and regulatory requirements.
  • Act as an authority on all aspects of clinical data standards, including industry guidelines and regulations.
  • Establish, lead, and actively participate in Data Standards Governance meetings.
  • Identify opportunities to optimize and integrate clinical trial data acquisition to improve efficiency and quality.
  • Contribute to the implementation of future strategies, technology-enabled processes, and tools related to clinical trial standards, change control management, and standards information exchange.
  • Stay informed on evolving industry and regulatory requirements for data standards and submissions, interpret guidance, and perform impact assessments to determine optimal implementation strategies.

In support of the clinical trial portfolio, the CDSM will:

  • Develop and maintain the Clinical Data Standards library.
  • Assist CDMs and DMLs in creating study-specific CRFs and SDTM metadata, applying standards at the trial level.
  • Provide training to internal teams on the use of clinical data standards.
  • Review SDTM conversions and oversee trial-level data quality control.
  • Escalate issues appropriately to the CTT or relevant program teams.

Additional contributions may include:

  • Leading or participating in process improvement initiatives focused on data standardization.
  • Taking part in regulatory inspections and internal audits when required.

Qualifications

  • Strong knowledge of ICH-GCP and other applicable regulations
  • Expertise in CDISC standards (SDTM, CDASH)
  • Strong attention to detail and analytical skills
  • Ability to work independently
  • Excellent communication and interpersonal skills
  • Fluent English (written and spoken)
  • Minimum of 8 years’ experience in Clinical Data Management (biotech experience advantageous)
  • Proven track record in a Data Standards team
  • Deep understanding of clinical development processes
  • Good working knowledge of applicable regulatory guidelines

What we offer:

  • We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
  • We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
  • Side activities will be organised regularly, to achieve a close collaboration within our team
  • We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
  • We contribute to a number of charities & support the research and / or the patients in our industry.
Apply here