Associate Director, Clinical Data Management

The Associate Director, Data Collection Data Steward, Global Data Management and Standards (GDMS), Global Clinical Data Standards (GCDS) provides program-level oversight of data standards, guiding study teams on library use and first-line governance while advancing new/modified standards and business processes. Lead Therapeutic Area Standards Teams (TASTs), training, support information governance, track conformance/benefits, and mentor junior staff.

• Define and maintain standard data collection (EDC [Electronic Data Capture] and non-EDC modalities) definitions aligned with industry standards (e.g., CDISC [Clinical Data Interchange Standards Consortium]) and Health Authority regulations and guidance; ensure harmonization across the clinical lifecycle (collection, analysis and reporting, and submission).
• Participate and lead organization initiatives as needed.
• Support audits and inspections as required.
• Support assigned information governance reviews (e.g., triage, impact assessment, curation, and stakeholder feedback/continuous improvement) via TAST (Therapeutic Area Standards Teams) and the SLIC (Shared Clinical Data Standards Council) governance teams.
• Develop and deliver Standards training and best-practices to cross-functional teams.
• Participate in training development, training delivery, and mentoring to members of the Global Clinical Data Standards team.
• Engage in industry forums, maintaining network of contacts, and influence industry strategic direction and clinical data standards development.
• Identify trends in developments of technologies, evolution in industry standards and regulatory requirements, and identify implications on our company's standards implementations.
• Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.
• Provide oversight and expertise within one or multiple TAs (Therapeutic Areas) on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.
• Work as a sitting member of the core design team for assigned studies and provide first line governance support for changes to existing library forms and new content.
• Support the development of future standards libraries (including in new therapeutic areas) and reviews of existing processes within SOPs (Standard Operating Procedures), WIs (Work Instructions), etc., ensuring they are in-line with quality requirements.
• Participate in assigned operational and study team forums ensuring clinical data standards align with industry standards, our company's standards and processes, and information management best practices.
• Support the definition and maintenance of the data collection
  
  Functional Area
  
  business processes and supporting technologies related to the definition, maintenance, application, and sharing of clinical data standards.

• Associate’s degree and a minimum of 15 years’ clinical data management or standards experience (or related discipline)
• Bachelor’s Degree and a minimum of 8 years’ clinical data management or standards experience
• Advanced Degree (Masters or Doctorate) and a minimum of 4 years’ clinical data management or standards experience

• Adaptability
• Adaptability
• Building Capability
• Clinical Database Programming
• Clinical Data Management
• Clinical Data Standards
• Coaching
• Competency Management
• Compliance Activities
• Data Analysis
• Data Management
• Data Quality Assurance
• Data Reporting
• Data Validation
• Detail-Oriented
• Enterprise Leadership
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Implement Training Programs
• Interpersonal Relationships
• Mentoring Staff
• Opera…