Job Description
Key Responsibilities
- Lead and oversee Data Management operations within the assigned geography, ensuring quality, compliance, operational excellence, and inspection readiness.
- Drive resource planning, workload balancing, and performance monitoring in partnership with operational stakeholders.
- Ensure consistent implementation of GDMS (Global Data Management and Standards)/GCTO (Global Data Clinical Operations) standards, regulatory requirements, and best practices.
- Manage operational risks, support continuous improvement, change initiatives, and cross-regional alignment.
- Build, develop, and lead high-performing teams through coaching, onboarding, talent development, and performance management.
- Lead hiring, workforce planning, employee engagement, and budget management.
- Coaches, inspires and empowers team members, creating the support structures and clarity needed for high performance.
Technical Expertise
- Strong knowledge of clinical data management, clinical trial lifecycle including study start-up processes, and industry regulations (GCP, 21 CFR Part 11).
- Experience with data standards, data flow, quality oversight, and inspection readiness.
- Proficiency in resource planning, operational metrics, and continuous improvement methodologies.
- Ability to drive high-quality clinical data design, validation, delivery, and audit preparation.
Leadership & Professional Skills
- Exceptional stakeholder management, communication, influencing and presentation skills across global, cross-functional environments.
- Proven people leadership with a strong focus on coaching, mentoring, talent development, and team performance.
- Ability to lead through influence, foster collaboration, and drive alignment without direct authority.
- Strong decision-making, problem-solving, adaptability, and resilience in dynamic environments.
- Demonstrated success in leading organizational change, innovation, and continuous improvement.
- Fluent English with excellent written and verbal communication skills.
Enterprise Leadership Skills
- Execution Excellence | Drives reliable, high-quality delivery within their team - developing core functional capabilities and KPI-driven measurement approaches (e.g., time-to-lock, query rates, error reduction) to track progress, improve outcomes, and support consistent, submission-ready outputs across studies.
- Strategic Planning | Thinks strategically within the assigned scope and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT.
- Networking & Partnerships | Builds and sustains strategic internal and external relationships (cross-functional leaders, service providers, alliance partners, customers) within the assigned scope to advance functional area objectives.
Qualifications & Experience
- Advanced Degree (Masters or Doctorate) (preferred in Life Science, Data, Information Technology, Project Management or Business) with 4 years of related industry experience in data management, including demonstrated experience in clinical data management, clinical trial operations, and managing large diverse teams, and minimum 2 years of people leadership or management experience (direct or matrix leadership).
Required Skills
- Clinical Data Management
- Clinical Development
- Clinical Research
- Clinical Trials
- Data Analysis
- Data Extraction
- Data Integration
- Data Validation
- Delivery Management
- Enterprise Leadership
- Good Clinical Practice (GCP)
- People Leadership
- People Management
- Pharmacovigilance
- Project Management
- Stakeholder Management
- Strategic Planning
- Strategic Thinking
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
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.
Job Posting End Date: 10/25/2026