Director, Clinical Data Management, Strategy and Operations Lead - Hybrid

Job DescriptionValidation Strategy, Governance & ComplianceDefine and lead enterprise Business System Validation strategy across domains and platforms, ensuring alignment with SDLC principles, data integrity requirements, regulatory expectations, and Quality Management Systems (QMS).Oversee validation risk management and governance, ensuring consistent application of risk-based validation approaches that balance compliance, quality, and business value.Partner with leadership to define and evolve enterprise validation capabilities, operating models, standards, and future-state strategies.Establish governance mechanisms to monitor validation readiness, cycle times, compliance posture, risks, capacity, and operational performance across platforms and programs, escalating gaps to senior leadership as appropriate.Lead strategic alignment of validation practices with platform roadmaps, digital transformation initiatives, automation programs, and technology delivery plans.Quality Oversight & Continuous ImprovementProvide oversight of validation execution quality, testing effectiveness, defect trends, and remediation activities across validation programs.Proactively identify systemic validation gaps, compliance risks, and process deficiencies, driving corrective and preventive actions (CAPAs) to strengthen quality, inspection readiness, and operational effectiveness.Drive continuous improvement initiatives that improve validation efficiency, standardization, scalability, and compliance outcomes.Lead operating model enhancements based on audit findings, regulatory expectations, inspection observations, lessons learned, and performance metrics.Documentation, Inspection Readiness & Operational ExcellenceGovern validation frameworks, policies, methodologies, standards, and lifecycle documentation to ensure consistent application and regulatory compliance across systems, platforms, automation solutions, databases, and digital capabilities.Establish and manage enterprise validation KPIs, scorecards, quality metrics, and governance dashboards to monitor compliance and organizational performance.Provide operational leadership, mentoring, and capability development across validation teams to ensure consistent execution and technical excellence.Ensure alignment of validation activities with enterprise security, privacy, data protection, records management, and QMS requirements.Lead preparation for internal audits, supplier assessments, and regulatory inspections by ensuring validation documentation, evidence, and processes remain inspection-ready.Oversee audit responses, inspection observations, CAPA commitments, and remediation activities to ensure timely and sustainable resolution.Represent Business Validation Services in enterprise governance, quality, compliance, and Center of Excellence forums to drive harmonization of standards, templates, methodologies, and best practices across the organizationAdditional responsibilitiesPartner with BVSV and Platform Services leadership to align validation strategy, portfolio priorities, resource capacity, organizational objectives, and delivery commitments, ensuring effective execution across the validation organization and supported platforms.Establish and monitor enterprise validation KPIs, dashboards, scorecards, and governance forums to provide visibility into validation readiness, compliance posture, inspection readiness, operational performance, risks, resource utilization, and capacity planning.Drive operational excellence across the Business Validation Services organization through standardization, automation, AI-enabled validation capabilities, workforce planning, and continuous improvement initiatives that enhance efficiency, quality, scalability, compliance, and business outcomes.Provide operational oversight for the validation services portfolio, ensuring effective demand management, resource allocation, workload balancing, and delivery performance across programs and platforms.Lead organizational capability development and succession planning to ensure the validation organization maintains the skills, expertise, and capacity required to support current and future business needs.Monitor and communicate organizational performance, risks, compliance trends, and capacity constraints to leadership, driving timely decisions and corrective actions as needed.Strategy, Planning & PrioritizationPartner with BVSV and Platform Services leadership to translate strategy into priorities, roadmaps, operational plans, and measurable outcomes.Establish an integrated planning process linking demand, portfolio commitments, resources, capacity, and organizational priorities.Facilitate prioritization and investment discussions to ensure focus on the highest-value opportunities.Monitor progress against strategic objectives and identify risks, dependencies, and areas requiring leadership action.Operational Governance & Leadership EnablementLead the governance framework for BVSV and Platform Services, including leadership forums, decision management, escalation processes, and performance reviews.Serve as a strategic partner and Chief of Staff to the leadership team.Ensure decisions, commitments, and actions are tracked through execution.Develop executive communications, strategic updates, and leadership materials.Portfolio, Demand & Capacity ManagementProvide an integrated view of service demand, delivery commitments, backlog, resource capacity, and organizational priorities.Support intake, assessment, and prioritization processes across validation and platform services.Identify capacity constraints, competing priorities, and resource risks and support leadership decision-making.Ensure commitments remain aligned with available resources and strategic objectives.Performance, Metrics & Business InsightsEstablish and maintain organizational KPIs, dashboards, scorecards, and performance reporting.Provide leadership visibility into service performance, demand, capacity, quality, risks, and strategic outcomes.Drive measurement of business value, operational efficiency, quality improvements, and organizational performance.Translate data into actionable insights and recommendations.Operational Excellence & Continuous ImprovementLead operational excellence and transformation initiatives across BVSV and Platform Services.Drive simplification, standardization, automation, and process improvement opportunities.Promote data-driven decision-making and adoption of AI and automation capabilities where appropriate.Ensure improvements are sustainable and aligned with organizational goals.Technical skillsUnderstanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices)Deep experience in Program and project governance and enterprise risk managementAdvanced knowledge of automation and AI testing guard rails, including validation of ML models and automated testing pipelinesStrong understanding of operations of functionsNon-technical skillsExcellent communicator with the ability to translate technical and operational priorities into clear, actionable directionDistills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions.Ability to define and execute organizational strategy for validation operations across regionsDemonstrated success managing large, varied perspectives, and geographically distributed teamsStrong understanding of operational, financial, and compliance dimensions of global data deliveryCapable of leading transformation initiatives and fostering innovation across complex organizationsLeads through influence across functions/geographies; mentors global cohorts; provides structured feedback.Engages vendor, data, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composureEnterprise Leadership SkillsBusiness Savviness | Anticipates business and regulatory issues and shapes strategy accordingly; connects technical expertise to organizational and industry context to make strategic recommendationsInfluence | Leads large teams / projects, helps shape departmental strategy influences leaders, peers, and cross-functional partners to align on decisions and strategic directionChange CatalystDrives improvements (e.g., organizational and cultural changes) with broader impact; demonstrates adaptability and ability to collaborate with others to make change successful; helps others overcome resistance to changeQualifications & experience:Bachelor's Degree with a minimum of 10 year's experience working in relevant field for associated job description (related technical role), as well as:People management skillsDemonstrated deep subject matter expertise in relevant discipline PMP, Change management and communicationORAdvanced Degree (Masters or Doctorate) with a minimum of 8 year's experience working in relevant field for associated job description, as well as:People management skillsclinicaltrialjobsEligibleforERP#GDMSRequired Skills: Adaptability, Business Agility, Business Decisions, Business Process Improvements, Change Management, Clinical Data Management, Decision Making, Enterprise Leadership, Good Clinical Practice (GCP), Organizational Leadership, Planning, Situational Leadership, Stakeholder Management, Strategic Leadership, Strategic Planning, Strategy DeploymentPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$173,200.00 - $272,600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:YesHazardous Material(s):NoJob Posting End Date:10/2/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. SummaryLocation: USA - New Jersey - RahwayType: Full time