Director, Clinical Data Management, Global Data Management and Standards

Job Description

The Director Data Collection Data Steward (M-track) leads teams that create maintain and govern clinical data standards and libraries end-to-end acting as escalation point for complex governance and ensuring quality and consistency across systems (e.g. Veeva) resourcing and portfolio prioritization. Partner across functions on metrics risk and industry engagement while leading training strategy and departmental initiatives.

Responsibilities & Primary Activities:

• Accountable for oversight of teams defining and maintaining 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; working with DCDS (Data Collection Data Steward) team members to ensure harmonization across clinical lifecycle and across studies.

• Identify opportunities leads or participates in organizational initiatives as needed.

• Support audits and inspections as required.

• Participate in defining and maintaining the governance model for clinical data standards (e.g. define forum purposes & scope decision rights and escalation ladders); Participate in executive reviews.

• Oversee the design and delivery of Standards training and best-practices to cross-functional teams.

• Provide operational expertise and guidance through training development training delivery and mentoring to members 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 cross-functional alignment with GDMS/ Global Clinical Trial Operations (GCTO)/ GCD Global Clinical Development) and partner functions on priorities funding and resourcing; represent the remit in leadership forums.

• 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.

• Support direct reports who actively participate and represent data standards as a sitting member for assigned design teams. Serve as an escalation point for study-level design core teams as needed.

• Provide prioritization and ensure appropriate resource allocation to future standards library development activities and/or new and/or modified processes.

• Provide expertise and guidance to frame options to facilitate decision making.

• Contribute to the development of the strategic direction for new processes and tools supporting clinical data standards and information management capabilities. Draft implementation plans.

• Work with leadership and colleagues to define and implement Standards metrics (e.g. conformance reuse change rationale); support tracking root-cause identification and synthesis of findings.

• Work with fellow Global Clinical Data Standards leadership on prioritization and delivery of the Book of Business set the strategic vision for the Global Clinical Data Standards organization new functional programs/projects and governance demands.

• Actively participate in cross-functional (e.g. GDMS/GCTO/GCD Global Clinical Development) strategic projects

• Act as an escalation point on governance decisions including changes to existing library forms and new content.

• Accountable for oversight of the integrity of data collection standards libraries and associated components.

• Serve as a member of the GCDS (Global Clinical Data Standards) Leadership Team and proactively engage with stakeholders inside and outside of Global Clinical Data Standards and across global sites to drive efforts critical to the success of Global Clinical Data Standards and GDMS (Global Data Management and Standards) more broadly.

• Participate in assigned operational and study team forums ensuring clinical data standards align with industry standards our Company standards and processes and information management best practices.

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 worklife sustainability; anticipate obstacles and adjust plans.

• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.

• Manage an operating budget and optimize spend against priorities.

• Align teams around a clear direction; facilitate team/functional meetings.

• Provide concise decision-ready updates and status reporting to leadership and partners.

• Our Research & Development Division Clinical Operations

• 500 / M3

• Senior Director-level Data Collection Data Steward (M-track) or Head of Global Clinical Data Standards

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 Reviewers Guide ADRG Analysis Data Reviewers Guide )

• Deep understanding of and experience with clinical development trial processes including data management and worldwide regulatory DM (Data Management) & reporting requirements

• Demonstrated 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 end-to-end 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.

Preferred:

• Member of the Association of Clinical Research Professionals Certified Professional (ACRP CP)

• Experience managing clinical data management processes including eCRF (electronic Case Report Form) design clinical database development and validation user acceptance testing external data management data extraction data transformation to SDTM and analysis & reporting

• Knowledge of clinical data metadata & information management principles and practices new technologies and regulatory requirements for submission deliverables

• Knowledge of FAIR (Findable Accessible Interoperable Reusable) and ALCOA (Attributable Legible Contemporaneous Original Accurate) principles and their application to information management and stewardship

• Ability to leverage technical solutions to manage functional and/or project deliverables and associated quality.

• Ability to use programming and other applications to generate insights from data

• Experience managing an organization responsible for data management delivery in a regulated environment (i.e. systems development validation implementation change management)

• PMP (Project Management Professional) certification and/or experience in project management

Non-technical knowledge skills and abilities:

• Exceptional communication and collaboration across cross-functional and global teams; tailors messaging up across and down; crafts decision-ready narratives and frames options risks and recommendations for senior leaders and direct reports.

• Cross-functional leadership through influence motivating geographically different teams guiding work across teams/geographies and fostering an inclusive high-trust culture.

• Strong judgment and accountability operating effectively in ambiguity managing escalations and driving consensus on process and technology improvements (including RCA Root Cause Analysis /CAPA Corrective and Preventive Action where applicable).

• Inclusive team leadership fostering psychological safety enabling knowledge sharing and supporting the development of communities of practice.

• Ability to recruit and retain talent and plan resourcing across regions and sourcing models (FTE Full-Time Equivalent/contingent/on- and off-shore).

• Continuous improvement and operational excellence mindset proactively identifying and advancing enhancements to ways of working tools and governance.

• Ability to drive adoption of standardized methods mobilizing cross-functional adoption and support.

Enterprise Leadership Skills:

• Innovation Challenge current thinkingExplore alternative ways to view and solve problems and achieve results; leverage innovation tools creative processes and different cross-functional experts to generate ideas; combine ideas in unique ways; make times to incubate ideas; thoughtfully evaluate alternatives and then select the best ideas for experimentation.

• Ownership and Accountability Provide support without removing task ownershipSuggest resources and provide assistance or coaching as needed; offer timely specific feedback to reinforce effective performance and redirect less effective performance; express confidence in the individual.

• Networking and Partnerships Involve othersAsk others for their opinions and ideas to gain their support when clarifying the situation developing solutions exploring needed resources and committing to action.

Qualifications & Experience:

Bachelors Degree and minimum of 10 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 3 years people management experience (direct or matrix)

• Demonstrated deep subject matter expertise

OR

Advanced Degree (Masters or Doctorate) and minimum of 8 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 3 years people management experience

• Demonstrated deep subject matter expertise

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