Senior Director, Clinical Data Management. - Hybrid

MSD•Rahway, PA

3d•Hybrid

About The Position

The Senior Director, Data Collection Data Steward is a member of the Global Clinical Data Standards (GCDS) Leadership Team. This leader sets strategy and oversees the standards delivery framework, governance, and operations, including planning, resourcing, process excellence, and innovation. The role drives enterprise metrics and outcomes, serves as an escalation point for governance, represents the company externally, and leads people management, objectives, talent, budgets, and communications. The position provides strategic direction and oversight for clinical data collection standards, standards libraries, training, governance, processes, tools, and information management capabilities. It partners across GCDS, Global Data Management and Standards (GDMS), Global Clinical Trial Operations (GCTO), Global Clinical Development (GCD), strategic partners, and global sites. The Senior Director supports audits and inspections, leads cross-functional initiatives, communicates implementation plans and metrics to stakeholders and executive leadership, and helps prioritize and deliver the GCDS book of business and governance demands. The role also leads and develops geographically distributed teams and coordinates onshore, offshore, and contingent resources. Responsibilities include setting objectives and priorities, coaching and performance reviews, career development, hiring, employee relations in partnership with HR, workload planning, budget management, and leadership communications. The role is hybrid, based primarily in North Wales (Upper Gwynedd), Pennsylvania, with 10% travel and a first/day shift.

Requirements

Bachelor’s degree and at least 13 years of experience in Clinical Data Management or a related discipline, including at least 3 years in clinical data standards development or metadata management; at least 5 years of people management experience (direct or matrix); and demonstrated deep subject matter expertise; OR an advanced degree (Master’s or Doctorate) and at least 10 years of relevant experience, including at least 3 years in clinical data standards development or metadata management, at least 5 years of people management experience, and demonstrated deep subject matter expertise.
Extensive experience managing and governing clinical information standards and related activities, including development and implementation of clinical data standards.
Deep knowledge and experience applying industry standards, including controlled terminologies, CDISC, CDASH, SDTM, ADaM, and HL7, and requirements for analysis, reporting, and submission deliverables such as SDRG, ADRG, and Define.xml.
Deep understanding and experience with clinical development trial processes, including data management and worldwide regulatory data management and reporting requirements.
Ability to understand program-level clinical and business requirements and the impact of standards.
Strong knowledge of the drug discovery process and ICH and GCP guidelines.
Advanced knowledge across more than two therapeutic areas and ability to drive consistency across studies in clinical development programs or therapeutic areas.
Knowledge of analysis and reporting, electronic data capture, and external supplier data.
Ability to take an enterprise-wide view of study needs, including controlled terminology, SDTM, analysis and reporting, submission targets, and deliverables, and ensure appropriate application of standards.
Ability to interpret study protocols and protocol requirements to understand study design and facilitate cross-functional understanding of data types and sources that are translated into high-quality, compliant data standard definitions.
Exceptional communication and collaboration across cross-functional and global teams; ability to tailor messaging and craft decision-ready narratives for senior leaders and direct reports.
Strategic leadership and ability to align diverse teams and stakeholders around shared objectives and long-term direction.
Influential people leadership, including motivating cross-functional and geographically diverse teams, building capability and consistency, and fostering an inclusive, high-trust culture.
Sound judgment and decision-making in ambiguity, escalation management, and cross-functional consensus-building on process and technology improvements, including RCA and CAPA where applicable.
Inclusive leadership and talent stewardship, including psychological safety, communities of practice, and recruiting, developing, and retaining talent across regions and sourcing models.
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 standardized ways of working and measuring adoption.
Ability to recruit and retain talent and plan resourcing across regions and sourcing models, including FTE, contingent, onshore, and offshore resources.
Strategic planning skills to define information strategies and develop standards- and technology-enabled approaches, including cross-functional alignment, implementation, communication, and change management.
Networking and partnership skills to involve others, gain support, develop solutions, identify needed resources, and commit to action.
Innovation skills, including exploring alternative approaches, leveraging creative processes and cross-functional expertise, evaluating alternatives, and selecting ideas for experimentation.

Nice To Haves

ACRP Certified Professional (ACRP-CP) membership or credential.
Experience managing clinical data management processes, including eCRF design, clinical database development and validation, user acceptance testing, external data management, data extraction, transformation to SDTM, and analysis and reporting.
PMP certification and/or project management experience.
Knowledge of clinical data metadata and information management principles and practices, new technologies, and regulatory requirements for submission deliverables.
Knowledge of FAIR and ALCOA principles and their application to information management and stewardship.
Ability to leverage technical solutions to manage functional or project deliverables and associated quality.
Ability to use programming and other applications to generate insights from data.

Responsibilities

Set strategy and oversee the standards delivery framework, governance, and operations, including planning, resourcing, process excellence, and innovation.
Drive enterprise metrics and outcomes; serve as an escalation point for governance and study-level design when needed; represent the company externally.
Provide oversight and guidance for defining and maintaining standard data collection definitions for EDC and non-EDC modalities, aligned with industry standards and Health Authority regulations and guidance.
Identify opportunities and lead or participate in organizational initiatives; support audits and inspections as required.
Manage timely delivery of standards and governance deliverables across GCDS sub-units, including resource forecasting, process optimization, operations reviews, and strategic innovation initiatives.
Provide strategic direction for standards training, best practices, training materials, delivery, and mentoring of the Global Clinical Data Standards team.
Participate in industry forums, maintain external networks, and influence industry strategic direction and clinical data standards development.
Build and sustain senior stakeholder networks across GDMS, GCTO, GCD, and strategic partners; broker decisions and remove systemic blockers.
Provide oversight and expertise in data collection and transformation design and data modeling within one or more therapeutic areas, ensuring consistency with established standards guidelines.
Participate in standards governance initiatives, forums, and reviews, including TAST and SLIC, and lead or participate in cross-functional strategic projects.
Oversee development of future standards libraries and new or modified processes; develop strategic direction for processes and tools that support clinical data standards and information management capabilities.
Communicate implementation plans to cross-functional stakeholders and executive management as appropriate.
Prioritize and oversee standards metrics and communicate them cross-functionally to Executive Leadership.
Collaborate with GCDS leadership on prioritization and delivery of the Book of Business, functional programs and projects, and governance demands.
Serve as an escalation point for governance decisions, including changes to existing library forms and new content.
Work with the GCDS ELT to define strategic direction and prioritization for data collection libraries and associated components.
Engage stakeholders inside and outside GCDS and across global sites to advance efforts critical to GCDS and GDMS.
Set team objectives aligned to organizational goals, assign work, and establish priorities.
Conduct check-ins and annual reviews, coach for performance, provide recognition, and develop career plans and growth opportunities.
Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR; ensure appropriate training and mentoring.
Balance workloads, anticipate obstacles, adjust plans, and coordinate onshore, offshore, and contingent resources to ensure role clarity and effective handoffs.
Manage an operating budget and optimize spending against priorities; align teams around direction and facilitate team or functional meetings.
Provide concise, decision-ready updates and status reporting to leadership and partners.
Define information strategies and approaches that use standards and technologies to optimize business processes, including adoption of regulations, industry standards, new standards, and tools.
Engage partners in clarifying situations, developing solutions, exploring resources, and committing to action; explore and evaluate innovative alternatives and select ideas for experimentation.