Senior Director Clinical Data Management

Merck•North Wales, PA

2d•$173,200 - $272,600•Hybrid

About The Position

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). Drive enterprise metrics and outcomes, act as an escalation point for governance, represent the company externally, and lead people management (objectives, talent, budgets, and communications).

Requirements

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.
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.
Strategic leadership, with the ability to align diverse teams and stakeholders around shared objectives and long-term direction.
Influential people leadership, leading through influence to motivate cross-functional and geographically diverse teams, build capability and consistency, and foster an inclusive, high-trust culture.
Sound judgment and decision-making, operating effectively in ambiguity, managing escalations, and driving cross-functional consensus on process and technology improvements (including RCA [Root Cause Analysis]/ CAPA [Corrective and Preventive Action] where applicable).
Inclusive leadership and talent stewardship, fostering psychological safety and communities of practice, and recruiting, developing, and retaining top talent across regions and sourcing models (FTE/contingent/on- and off-shore).
Advanced stakeholder management and negotiation skills across functions, geographies, and seniority levels.
Ability to lead change, embed innovation, and drive continuous improvement and operational excellence, including adoption of standardized ways of working and measurement of uptake.
Continuous improvement and operational excellence mindset, proactively identifying and advancing enhancements to ways of working, tools, and governance.
Ability to recruit and retain talent and plan resourcing across regions and sourcing models (FTE [Full Time Equivalent]/contingent/on- and off-shore).
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
Client-Focused
Clinical Data Management
Clinical Study Management
Conflict Resolution
Data Processing
Data Validation
Detail-Oriented
Ethical Standards
Good Clinical Practice (GCP)
Innovation
Persuasion
Pharmaceutical Terminology
Protocol Review
Service Provider Management
Strategic Planning

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

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.
Act as an escalation point on governance decisions, including changes to existing library forms and new content.
Working in collaboration with GCDS ELT to define the strategic direction and prioritization for the data collection libraries and associated components.
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.
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.