Senior Director, Clinical Data Management. - Hybrid

Merck•North Wales, PA

1d•$173,200 - $272,600•Hybrid

About The Position

The Senior Director, Data Collection Data Steward serves on the Global Clinical Data Standards (GCDS) Leadership Team, setting strategy and overseeing standards delivery, 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 the definition, maintenance, delivery, and governance of clinical data collection standards and related processes, tools, training, and information management capabilities. It works across GCDS sub-units and with stakeholders throughout Global Data Management and Standards (GDMS), Global Clinical Trial Operations (GCTO), and Global Clinical Development (GCD) to ensure standards align with industry practices and regulatory requirements. The role also leads and develops teams, manages resources and budgets, communicates metrics and implementation plans to executive leadership, and contributes to industry standards development and strategic direction. The role is based in North Wales (Upper Gwynedd), Pennsylvania, with a hybrid work arrangement and approximately 10% travel. The position is a regular employee role, with no relocation offered and no visa sponsorship. The stated salary range for the primary location is $173,200 to $272,600, with eligibility for an annual bonus and long-term incentive, if applicable.

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 and at least 5 years of people management experience (direct or matrix); 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 and at least 5 years of people management experience.
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.
Understanding of program-level clinical and business requirements and the impact of standards.
Strong knowledge of the Drug Discovery Process, ICH, and GCP guidelines.
Advanced knowledge across more than two therapeutic areas and ability to drive consistency across studies in clinical development programs and/or therapeutic areas.
Knowledge of analysis and reporting.
Expertise in Electronic Data Capture and external supplier data.
Ability to take an enterprise-wide view of study needs, including Controlled Terminology, SDTM, analysis and reporting, and submission targets and deliverables, to ensure appropriate application of standards.
Ability to interpret study protocols and design requirements, and translate protocol requirements into cross-functional understanding of data types and sources and high-quality, compliant data standard definitions.
Exceptional communication and collaboration across cross-functional and global teams, including tailoring communications and producing 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.
People leadership that motivates cross-functional and geographically diverse teams, builds capability and consistency, and fosters an inclusive, high-trust culture.
Sound judgment and decision-making in ambiguous situations, including management of escalations and building cross-functional consensus on process and technology improvements, including RCA and CAPA where applicable.
Inclusive leadership and talent stewardship, including fostering psychological safety and 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 adoption and measurement of standardized ways of working.
Ability to plan resourcing across regions and sourcing models, including FTE, contingent, onshore, and offshore resources.
Enterprise leadership skills in strategic planning, networking and partnerships, and innovation.

Nice To Haves

Association of Clinical Research Professionals Certified Professional (ACRP-CP) membership.
Experience managing clinical data management processes, including eCRF design, clinical database development and validation, user acceptance testing, external data management, data extraction, SDTM data transformation, 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 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 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 the design and delivery of Standards training and best practices to cross-functional teams.
Oversee development of training materials, training delivery, and mentoring for the Global Clinical Data Standards team.
Represent the company in industry forums, maintain a network of contacts, and influence industry strategy 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 expertise and oversight within one or more therapeutic areas on data collection and transformation design and data modeling, ensuring consistency with established standards guidelines.
Provide strategic direction and participate in standards governance initiatives, forums, and reviews, including TAST and SLIC.
Lead or actively participate in cross-functional strategic projects.
Serve as an escalation point for study-level design and governance decisions, including changes to existing library forms and new content.
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.
Oversee and communicate implementation plans to cross-functional stakeholders and executive management, as appropriate.
Prioritize and oversee standards metrics and communicate metrics cross-functionally to Executive Leadership.
Work with GCDS leadership to prioritize and deliver the Book of Business, functional programs and projects, and governance demands.
Collaborate with the GCDS ELT to define strategic direction and prioritization for data collection libraries and associated components.
Engage proactively with internal and external stakeholders and global sites to advance priorities important to GCDS and GDMS.
Set clear employee objectives, assign work, and set priorities aligned with organizational goals.
Conduct regular check-ins and annual reviews, coach for performance, and provide recognition.
Develop career plans and growth opportunities, support promotion cases, and ensure appropriate training and mentoring.
Lead recruiting and hiring and manage sensitive employee-relations matters in partnership with HR.
Balance workloads, support sustainable work practices, anticipate obstacles, and adjust plans.
Coordinate onshore, offshore, and contingent resources; ensure role clarity and effective handoffs.
Manage an operating budget and optimize spending against priorities.
Align teams around direction and facilitate team and functional meetings.
Provide concise, decision-ready updates and status reports to leadership and partners.