Senior Director, Functional Area Geography Lead, Clinical Data Management
Rahway, NJ - USA
Job Summary
Job Description
The Senior Director Functional Area Geography Lead GDMS Clinical Data Management (CDM Country Lead) provides strategic direction and governance to ensure consistent data-management delivery quality and compliance. The role oversees resource optimization operational performance and organizational effectiveness driving cross-functional alignment with functional and GDMS (Global Data Management & Standards) leadership to enhance delivery talent development and scalability within assigned country.
Strategic Leadership & Geographic Strategy:
Provide strategic direction within assigned country; ensure consistent execution quality and compliance; develop country-specific objectives aligned with organizational priorities.
Serve on the functional areas leadership team as assigned; represent geographic and functional perspectives in GDMS (Global Data Management & Standards) LT (Leadership Team)/enterprise forums and audits as needed.
Lead or participate in cross-functional collaborations with non-GDMS partners and enterprise support functions to achieve geographic strategic and operational objectives.
Communicate clear narratives to executives on risks trade-offs and decisions; champion innovation automation and risk-based data-management practices; share lessons and maintain quality oversight across geographies.
Lead the operating model and optimization strategy for the assigned geography integrating functional area and GDMS global strategic objectives.
Actively identify and support functional area capability development and implementation aligned with industry best practices and business needs; drive adoption of technology across relevant organizations consistent with agreed-upon principles and organizational priorities.
Inspire teams toward shared goals for our companys Clinical Development Portfolio GCTO (Global Clinical Trial Operations) objectives and cross-functional partners.
As assigned serve as the GDMS Site Head for the relevant country
Partner with Country and Regional business support functions (e.g. HR Finance) to enable local business priorities.
Operational Governance Execution & Cross-Functional Alignment:
Coordinate workforce planning resource management and operational performance.
Serve as escalation point for country issues and oversee country-specific risk escalation and capacity-management processes; ensure local regulatory business and labor compliance.
Ensure geography/functional inspection readiness and compliant operational controls including for operational data change management and system releases.
Evaluate and implement process/technology improvements that enhance scalability standardization and quality; support operating model adoption and change management.
Lead complex cross-functional workstreams focus areas to be determined based on needs of the organization from idea/design to implementation and value realization.
Actively support and participate in metrics governance and performance reviews with Portfolio & Resource Operations Specialists to ensure transparent portfolio health and operational efficiency.
Actively manage OKRs (Objectives and Key Results) and performance metrics for assigned geography in alignment with broader GDMS goals and priorities; monitor dashboards and drive accountability.
Conduct enterprise and country scenario planning and implement resilience playbooks to ensure business continuity and protect critical work and service levels.
Provide concise decision-ready updates and status reporting to leadership and partners.
People Management & Talent Development:
Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
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 and oversee performance management activities including management of sensitive employee-relations matters in partnership with HR.
Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
Manage an operating budget and optimize spend against priorities.
Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.
Capability leadership (as assigned):
Sit on CDM leadership team as the representative for their assigned capability
Accountable for defining the strategic objectives and roadmap for capability development initiatives aligned to business needs and industry best practices.
Establish and oversee capability governance with GDMS / GCTO policies and enterprise digital / data initiatives.
Own development of critical capabilities (tools processes skills) aligned to industry best practices.
Drive consistent global rollout via playbooks guidance and implementation support; align cross-regional ways of working with partners.
Technical Skills
Strong understanding of end-to-end data management processes and systems used for data collection application of data standards cleaning/review reporting governance and use of operational and quality metrics to monitor performance.
Deep knowledge of ICH/GCP (International Council of Harmonization - Good Clinical Practices) guidelines and how they apply to clinical or safety data management activities.
Understanding of regulatory requirements quality frameworks and inspection/audit processes; ability to support inspection/audit readiness.
Proven experience implementing risk-based and digital data practices using data and automation to improve focus and quality.
Ability to use analytical and forecasting tools (dashboards capacity models) to inform resourcing planning and operational decisions.
Ability to define and enforce standards for integration reuse and scalability of data tools and solutions.
Proven financial stewardship including budget ownership workforce cost modeling and development of investment/value realization frameworks.
Knowledge of local-subsidiary operations (HR vendors facilities finance) and local compliance expectations.
Expertise in data-product governance (definitions lineage quality controls lifecycle) to maintain a global single source of truth.
Clinical Data ManagerSpecific Technical Skills
Ability to implement and execute inspection-readiness practices in collaboration with process & quality partners.
Demonstrated ability to drive high-quality clinical data collection design validation and delivery in alignment with protocol requirements.
Non-technical skills
Strategic leadership with the ability to align cross-functional and virtual teams and stakeholders around shared objectives.
Strong ability in negotiation and conflict resolution; aligning divergent priorities to enterprise outcomes and enforces clear responsibilities.
Effective facilitation of decision-making coordinating work across teams and driving timely resolution of complex issues.
Change leadership including executive influence and storytelling to shape decisions across senior leadership levels; ability to communicate with both the technical and business areas.
Demonstrated ability to drive large-scale change embed innovation and lead continuous improvement initiatives while ensuring adoption of standardized risk-based and digital practices.
Strong people leadership mentoring and development capabilities across multiple levels and geography; create a high-performance inclusive culture that attracts develops and retains talent.
Ability to integrate business operational and people dimensions into effective decision-making; demonstrated budget and business acumen.
Highly adaptable and resilient able to prioritize and perform effectively under pressure.
Demonstrated disciplined prioritization focused on critical metrics and initiatives.
Works independently with sound judgment exercising initiative while maintaining alignment with organizational priorities.
Tailors messaging up across and down with clear actionable feedback to direct reports.
Capability building focused on senior-level talent development and communities of practice.
Fluent in English with excellent written and verbal communication skills to clearly convey complex or technical information.
Enterprise Leadership Skills
Talent Growth: Build and sustain organizational talent for the geography by establishing systems to attract develop engage and retain top performers and by fostering an environment where people can realize their full potential to meet current and future business needs.
Strategic Planning: Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development clinical operations regulatory safety and IT.
Networking & Partnerships: Proactively builds and sustains strategic internal and external relationships (cross functional leaders service providers alliance partners customers) to accelerate functional area and geography-specific objectives.
Clinical Data Manager Qualifications & Experience
Bachelors Degree (or equivalent educational experience) in Life science Data or Information technology with 13 years of experience in data management including:
5 years of people management experience.
Demonstrated experience in clinical data management clinical trial operations and managing large global teams.
OR
Bachelors Degree (or equivalent educational experience) in any field not listed above with 18 years of experience in data management including:
5 years of people management experience.
Demonstrated experience in clinical data management clinical trial operations and managing large global teams.
OR
Advanced Degree (Masters or Doctorate) in Life Science Data Information Technology Project Management or Business with 10 years of related industry experience in data management including:
5 years of people management experience.
Demonstrated experience in clinical data management clinical trial operations and managing large global teams.
OR
Advanced Degree (Masters or Doctorate) in any field not listed above with 15 years of related industry experience in data management including:
5 years of people management.
Demonstrated experience in clinical management clinical trial operations and managing large global teams.
# eligibleforERP #GDMS #ONEGDMS
Required Skills:
Change Management Clinical Data Management Clinical Study Management Clinical Study Protocols Collaborative Leadership Competency Development Data Analysis Data Governance Data Management Data Processing Decision Making Ethical Standards Executive Leadership Good Clinical Practice (GCP) Leadership Theories Operating Models Organizational Leadership People Leadership Situational Leadership Strategic Leadership Strategic Planning Strategic Thinking Strategy DevelopmentPreferred Skills:
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The salary range for this role is
$173200.00 - $272600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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 Ordinance
Los 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 Ordinance
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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:
InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
08/21/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Exec
About Company
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicine ... View more