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Full-time
Posted 8d ago
Apply by Aug 12
~40 hrs/week
Responsibilities
The Director provides strategic and operational oversight for clinical data management activities within a defined geography. They are responsible for leading regional plans, managing staff performance, and ensuring compliance with global regulatory standards.
Requirements
The role requires extensive experience in clinical data management, team leadership, and cross-functional collaboration. Candidates must demonstrate expertise in GCDMP, SDTM, and organizational performance management to drive operational excellence.
Full job description
Job Description
The Director, Functional Area Geography Lead provides strategic and operational oversight for all functional area activities within a defined geography and team. The role defines and executes regional plans, manages staff performance and succession, and ensures compliance with local and global requirements while fostering collaboration, innovation, and the adoption of standardized and digital data-management practices.
Responsibilities
Strategic Leadership & Geographic Strategy:
· Provide strategic direction within assigned country or region; ensure consistent execution, quality, and compliance; develop region-specific objectives aligned with organizational priorities.
· Lead or participate in cross-functional collaborations with non-GDMS (Global Data Management & Standards) 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.
· Define and lead the functional area's operating model and multi-year optimization strategy for the assigned geography, integrating functional area and GDMS global strategic objectives.
· Actively identify and support functional area-specific capability expansion aligned with industry best practices and business needs; drive adoption of technology-deployment principles across relevant GCTO (Global Clinical Trial Operations) organizations.
· Drive high-quality, compliant, decision-ready data products and processes that enable teams to meet critical regulatory, clinical, and operational milestones within assigned functional area.
· Ensure inspection readiness, adherence to regional processes, and compliant controls for operational data, processes, and system changes in partnership with global and functional quality/process leaders.
· Analyze trends and performance data to identify opportunities for efficiency, quality, and engagement improvements; communicate insights in governance or leadership forums.
· Lead or oversee regional risk, escalation, and capacity management processes.
· Collaborate with Portfolio & Resource Operations Specialists to forecast needs, optimize capacity, and implement data-driven performance dashboards; resolve resourcing/performance bottlenecks; ensure transparent portfolio health and operational efficiency.
· Provide concise, decision-ready updates and status reporting to leadership and cross-functional partners, ensuring effective flow of communication within geography.
· Serve as escalation point for country/regional issues and oversee regional risk, escalation, and capacity-management processes; ensure local regulatory, business, and labor compliance.
· Lead or participate in cross functional global projects to support continuous improvement, capability development, and alignment.
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 spending against priorities.
· Coaches, inspires and empowers team members, creating the support structures and clarity needed for high performance.
Required Skills:
Adaptability, Clinical Data Management, Cross-Functional Collaboration, Good Clinical Data Management Practice (GCDMP), Inspection Readiness, Interdisciplinary Collaboration, Metadata Management, Organizational Performance Management, Study Data Tabulation Model (SDTM), Team Leadership
Preferred Skills:
Data Management, People Management, Quality Oversight, Strategic Leadership
Search 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:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
08/12/2026
*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.
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
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