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PURPOSE OF THE FUNCTION

The Clinical Data Standards Manager is a functional expert in the field of clinical data standards as defined by Regulatory Authorities and Industry Organizations, such as CDISC, and as required for clinical data submissions.

The CDSM advises and supports the Clinical Data Manager (CDM), Data Management Lead (DML) and the broader Clinical Trial Team (CTT) to ensure that clinical data is completed, accurate and consistent and meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations.

REPORTING LINE

Lead Data Standards

ROLES AND RESPONSIBILITIES

The CDSM will:

• Take a leadership role in cross-functional teams to create data standard driven end-to-end processes and solutions that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and regulatory requirements.

• Serve as a subject matter expert on all aspects of clinical data standards development that includes industry standards and regulations.

• Set up, lead or/and contribute actively in the Data Standards Governance meetings.

• Provide support to optimize data acquisition in clinical trials by exploring opportunities to streamline and integrate data, enhancing efficiency and data quality.

• Support and implement future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal and external stakeholders.

• Keep abreast of Industry and Regulatory Authority requirements related to data standards and data submission, interpret published data standards guidance documentation and perform impact assessments to decide on a strategy for implementation

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

• Develop and maintain the argenx Clinical Data Standards library

• Support CDM and DML in creation of study specific unique CRFs and SDTM metadata, implementing clinical data standards on trial level

• Ensure proper training of the CDM and other internal teams in the use of the argenx clinical data standards. Support CDM with review of the SDTM conversion and data QC on trial level.

• Perform proper issue escalation to other members of the CTT and/or Indication Development Team (IDT) as required

The CDSM will also participate in other activities but are not limited to:

• Lead/participate in initiatives on process improvements focussed on data standardization

• Participate in regulatory agency inspections and internal audits, when appropriate

SKILLS AND COMPETENCIES

• Knowledge of ICH-GCP and other applicable legislation

• CDISC standards (SDTM, CDASH)

• Eye for detail, analytical skills

• Able to work independently

• Strong communication and interpersonal skills

• Fluent in English (written and spoken)

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Master’s or Bachelor’s degree in Life Sciences, Information Technology or equivalent by experience

• At least 8 years experience in Clinical Data Management (Biotech experience is a plus)

• Experience of working in a Data Standards team

• In depth understanding of Clinical Development processes

• Good knowledge of the applicable regulatory guidelines