Associate Dir. FA Geo Lead, Colombia, GDMS CDM

Merck; Puerto Bogotá; On-site; COP 381,934,000 - 572,902,000; Full time

Job summary

Merck is seeking an Associate Director, CDM Geography Lead to oversee day-to-day data-management operations within the assigned geography, ensuring efficiency, quality, and inspection readiness across studies.

You will lead local teams, align with Global Data Management and Standards, drive workforce planning, and partner with regional leads to promote standardized practices and staff development in a fast-paced environment.

Qualifications

• Experience in data-management operations within clinical trials.
• Knowledge of GDMS and GCTO processes and regulatory expectations.
• Ability to lead multi-site teams and manage performance metrics.

Responsibilities

• Oversee day-to-day data-management execution within the geography, ensuring efficiency, quality, compliance, and inspection readiness.
• Review and provide input on work performed by direct reports.
• Develop local teams and align performance to GDMS standards; support onboarding and skill-building.

Skills

Data management

Clinical trials

Leadership

Regulatory knowledge

Quality assurance

Job description

Job Description

The Associate Director, CDM (Clinical Data Management) Geography Lead oversees day-to-day data-management operations and resources within the assigned geography. The role ensures operational efficiency, compliance, and quality delivery, supports regional strategy and resourcing, and partners with other leaders to promote consistent practices and staff development across sites.

Responsibilities

Strategic Leadership & Geographic Strategy : Oversee day-to-day data-management execution within the assigned geography; ensure efficiency, quality, compliance, and inspection readiness.

Responsible to review and provide input on work performed by direct reports.

Manage and develop local teams; align performance to GDMS (Global Data Management and Standards) standards and expectations; guide onboarding and technical skill-building.

Partner with Portfolio & Resource Operations Specialist team on workload tracking, capacity/utilization, and operational metrics; support near-term forecasting and workload balance across studies/TAs (Therapeutic Areas).

Ensure adherence to GDMS/GCTO (Global Clinical Trial Operation) processes and local regulatory requirements; drive consistent execution of GDMS ways of working.

Partner with functional leads to align oversight and promote consistent ways of working across regions.

Identify and escalation operational or compliance risks; support mitigation and preventive actions.

Share lessons learned and best practices within the geography; support change initiatives.

People Management Responsibilities

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.

Coaches, inspires and empowers team members, creating the support structures and clarity needed for high performance.

Qualifications, Skills & Experience

Technical skills

Working knowledge of data-management operations, quality standards (GDMS, GCTO), and clinical trial lifecycle.

Experience with data standards, data flow, and study start-up systems.

Proficiency in workload planning, resourcing systems, and performance metric tools.

Familiarity with continuous improvement methodologies

Understanding of local and global regulatory requirements, including Good Clinical Practice guidelines and 21 CFR Part 11, and processes.

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.

Understanding of inspection/audit processes and ability to contribute to audit readiness.

Non-technical skills

Exceptional communication and influencing skills, with the ability to engage and align stakeholders across functions, geographies, and levels to achieve shared objectives.

Effective coach, mentor and developing direct reports and teams to ensure high-level of performance, achieving satisfaction through advancement of others.

Strong stakeholder management and collaboration capabilities, fostering trust and effective partnerships to deliver consistent, high-quality outcomes.

Demonstrated ability to lead through influence, motivating and guiding cross-functional and virtual teams without direct reporting authority.

Highly adaptable and resilient, able to prioritize and perform effectively under pressure in a fast-changing environment.

Works independently with accountability, exercising sound judgment and initiative while maintaining alignment with organizational priorities.

Effective facilitator of decision‑making, coordinating the work of others and driving timely resolution of complex issues.

Fluent in English with excellent written and verbal communication skills, able to clearly convey complex or technical information to diverse audiences.

Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk‑based, and digital practices.

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 a