Director, Clinical Data Management, Global Data Management and Standards

MSD • Rahway, NJ

2d • Remote

About The Position

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.

Requirements

• Bachelor’s Degree and minimum of 10 year's 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 year's 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
• 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
• 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.
• Clinical Data Management
• Clinical Development
• Clinical Trials
• Collaborative Communications
• Data Validation
• eCRF
• Electronic Data Capture (EDC)
• Ethical Standards
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Metadata Management
• People Management
• Stakeholder Relationship Management
• Study Data Tabulation Model (SDTM)
• Team Leadership

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior