Data Standards Specialist, Global Clinical Data Standards (Hybrid)

Job Description

The Data Standards Specialists is responsible for:

• Defining standard collection and mapping data definitions aligned with industry (CDISC) standards and Health Authority regulations

• Ensuring the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables

• Supporting the definition of maintenance of additional standards library components

• Participates in standards data governance reviews

• The GCDS Data Standards Specialist may contribute to the definition and maintenance of business processes related to the definition, use, maintenance and sharing of clinical data standards 

• Support department initiatives and participate in cross-functional working groups and process improvement activities

  • Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company

• Maintain knowledge of new technologies, industry standards, regulatory requirements, and our Company guidelines and SOPs.

• Able to work independently or as a team member with equal effectiveness. Interacts with staff across multiple our Company sites

• May support any other project or perform any other data management task deemed appropriate by management

Education Minimum Requirement:

• Bachelor's degree with 1 year of clinical data management or standards experience

  • Or

• Associates degree with 3 years of clinical data management or standards experience

  • Or

• High School/GED degree with 7 years’ work years of clinical data management or standards experience

Required Experience and Skills:

• Advanced knowledge of clinical data standards development and implementation

• CDISC SDTM expertise: In-depth knowledge of and experience with applying the CDISC Study Data Tabulation Model (SDTM) 

• A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.

• Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines

• Knowledge of Analysis & Reporting

• Exceptional communication (oral and written) skills

• Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in time management (ability to prioritize & manage multiple projects) .

Preferred Experience and Skills:

• Electronic Data Capture expertise (e.g., InForm)

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If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and …