Senior Director Clinical Data Management

About the role

The Senior Director, Data Collection Data Steward (M-track) serves on the GCDS Leadership Team to set strategy and oversee the standards delivery framework, governance, and operations (planning, resourcing, process excellence, and innovation).

Responsibilities

• Provide oversight and guidance to teams as they 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.
• Identify opportunities, lead, or participate in organizational initiatives as needed.
• Support audits and inspections as required.
• Accountable for the management and timely delivery of standards and governance deliverables, coordinating efforts across GCDS sub-units including resource forecasting, process optimization, operations reviews, and strategic innovation initiatives.
• Provide oversight and strategic direction to the design and delivery of Standards training and best practices to cross functional teams.
• Provide oversight and strategic direction to teams in the development of training materials, training delivery, and mentoring of the Global Clinical Data Standards team.
• Act as a leader in industry forums, maintaining network of contacts, and influence industry strategic direction and clinical data standards development.
• Build and sustain senior stakeholder networks across GDMS/ Global Clinical Trial Operations (GCTO)/ GCD [Global Clinical Development]) and strategic partners; broker decisions and remove systemic blockers.
• Provide oversight and expertise within one or multiple TAs on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.
• Ability to provide strategic direction and participate in multiple Standards governance initiatives, forums, and reviews (e.g., TAST [Therapeutic Area Standards Team], SLIC [Shared Clinical Data Standards Council]).
• Lead and/or actively participate in cross-functional (e.g., GDMS/GCTO/GCD [Global Clinical Development]) strategic projects.
• Serve as an escalation point for study-level design, as needed.
• Provide oversight and strategic direction to teams in development of future standards libraries and/or new/modified processes.
• Develop the strategic direction for new processes and tools supporting clinical data standards and information management capabilities.
• Provide oversight and communication of the implementation plans to cross-functional stakeholders and executive management, as appropriate.
• Provide prioritization and oversight of standards metrics.
• Communicate metrics cross-functionally to Executive Leadership.
• Work with fellow GCDS leadership on prioritization and delivery of the Book of Business, new functional programs/projects, and governance demands.
• Work as an escalation point on governance decisions, including changes to existing library forms and new content.
• Serve as a core member of the GCDS (Global Clinical Data Standards) Leadership Team and proactively engage with stakeholders inside and outside of GCDS and across global sites to drive efforts critical to the success of GCDS and GDMS (Global Data Management and Standards) more broadly.

People Management Responsibilities

• Set clear objectives aligned to organizational goals; assign work and set priorities.
• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
• Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR.
• Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans.
• Career development and retention of talent.

Technical Skills

• Extensive experience managing and governing clinical information standards and related activities, including the development and implementation of clinical data standards.
• Deep knowledge of and experience with applying industry standards (e.g., Controlled Terminologies, CDISC [Clinical Data Interchange Standards Consortium], CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], ADaM [Analysis Data Model], & HL7 [Health Level Seven International]) and requirements for analysis & reporting and submission deliverables (e.g., SDRG [Study Data Reviewer’s Guide], ADRG [Analysis Data Reviewer’s Guide], Define.xml)
• Deep understanding of and experience with clinical development trial processes, including data management and worldwide regulatory DM (Data Management) & reporting requirements.
• Demonstrate understanding of program-level clinical and business requirements and impact of standards.
• Strong knowledge of the Drug Discovery Process, ICH (International Council for Harmonization) and GCP (Good Clinical Practice) guidelines.
• Demonstrate advanced knowledge across multiple (>2) therapeutic areas with ability to drive consistency across all studies in clinical development programs and / or therapeutic areas.
• Knowledge of Analysis & Reporting.
• Electronic Data Capture and external supplier data expertise.
• Ability to take an enterprise-wide view of study needs that is inclusive of Controlled Terminology, SDTM, analysis and reporting, and submission targets and deliverables to ensure appropriate application of standards.
• Ability to interpret the study protocol as it relates to study design. Ability to interpret protocol requirements to facilitate cross-functional understanding of data types and sources which are then translated into high quality, compliant data standard definitions.

Qualifications & Experience

• Bachelor’s Degree and minimum of 15 years experience in Clinical Data Management (or related discipline), including; 3 years needs to be in clinical data standards development or metadata management.
• Minimum of 10 years people management experience (direct or matrix).
• Demonstrated deep subject matter expertise OR Advanced Degree (Masters or Doctorate) and minimum of 13 years experience in Clinical Data Management (or related discipline), including: 3 years needs to be in clinical data standards development or metadata management Minimum of 10 years people management experience.
• Demonstrated deep subject matter expertise.