Global Clinical Data Standards, Senior Therapeutic Area Lead - Hybrid

Job Description

The Senior GCDS TA Lead is a subject matter expert in data standards for support of clinical data collection and/or transformation management that is compliant with health authority regulations.  

Primary activities may include, but are not limited to:

• Providing operational expertise and guidance through training development, training delivery and mentoring to members of the Global Clinical Data Standards team.

• Maintaining the integrity of standards libraries, ensuring processes as defined in SOPs and work instructions are in alignment with our company quality documentation standards.

• Maintaining knowledge of new and evolving industry and health authority guidance; assess impact to our Company's current implementation of end-to-end data standards.    

• Influencing industry strategic direction and clinical data standards development through active participation in industry organizations and forums. Maintain a communication network among industry peers for the purpose of identifying innovative processes and technology and best practices.

• Lead/participate in cross-functional data governance reviews and projects.

• Lead/participate in departmental and/or cross-functional working groups and process improvement initiatives.

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

• In conjunction with senior leadership, participate in corporate initiatives by providing guidance and direction in evaluating, re-engineering, designing, implementing, benchmarking, and training for new or enhanced processes, procedures, and technology.  Encourage practical applications of new ideas 

• Provide expertise on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.

• Work with leadership to define and implement KPIs and quality metrics reporting to assure high quality standard components.

• Lead and represent GCDS on TAST as required to ensure consistency across the various projects and protocols within the therapeutic areas.

• Ensure all therapeutic area work complies with the current standards.  Support the teams in their development of new and modified standards and submission to the required governing bodies. 

• Lead the review of departmental SOPs, reference documents, execution resources and implementation strategies. 

• Promote teamwork across GCDS by actively communicating and proactively sharing information.

Qualifications, Skills and Requirements

Education:

• B.A. or B.S. degree, preferably in life sciences, computer science or related discipline.

Experience:

• 10 years’ work experience which includes 6 years of data management experience and a minimum 4 years in clinical data standards development.

Knowledge and Skills:

• In-depth (advanced) knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml).

  • Expertise in various forms of data collection (e.g., eCRF, IRT, Central Lab Data)

  • Study Data Tabulation Model (SDTM) expertise

• Understanding of clinical data requirements for Analysis & Reporting

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

• Comprehensive knowledge of the clinical trial process including data management (e.g., data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.

• Advanced knowledge in two or more therapeutic areas

• Ability to work with clinical teams to assure consistency across all studies in a clinical development program and/or therapeutic area. 

• Exceptional education/training/facilitation skills

  • Ability to mentor cross functional colleagues in data standards and metadata management practices.

• Experience in defining and implementing continuous improvement projects

• Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.

• Ability to influence and drive decision making

• Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initia