Associate Director, Clinical Operations at Merck & Co. · MYS -…

This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures, and internal and external quality standards.

Under the oversight of the CRD or Head of Country Operations, the position is responsible for managing and overseeing a team of Clinical Operations Managers (COMs) and/or Clinical Trial Coordinators (CTCs).

This role plays a critical role in delivering country-specific clinical trial commitments and objectives, particularly during study start-up, while ensuring operational excellence, compliance, quality, and stakeholder alignment.

Key Responsibilities

Financial Management

• Own country and site budgets.

• Develop, negotiate, and complete Clinical Trial Research Agreements (CTRAs).

• Partner with local clinical teams to deliver clinical and financial contracts within fair market value guidelines.

• Oversee and track clinical research-related payments.

• Manage payment reconciliation at study close-out.

• Ensure compliance with FCPA requirements, Denied Parties Screening, and financial systems maintenance.

• Support financial forecasting and operational budget tracking in conjunction with the CRD, where applicable.

Regulatory Submissions & Local Documentation

• Execute and oversee country-level clinical trial submissions and approvals for assigned protocols.

• Develop local language materials, including:

  • Informed Consent Forms (ICFs)

  • Study-related translations

  • Other required local documentation

• Collaborate with IRBs/IECs and Regulatory Authorities on submission and approval activities.

Operational & Quality Oversight

• Manage country deliverables, timelines, and protocol outcomes to meet local commitments.

• Ensure quality and compliance standards are maintained across assigned protocols.

• Contribute to the development and improvement of local and global SOPs.

• Oversee contract workers, including COMs, CTCs, and local vendors.

• Manage direct reports through:

  • Performance management

  • Development planning

  • Coaching and mentoring

  • Issue resolution

Stakeholder Management & Collaboration

• Work closely with internal and external stakeholders to ensure country deliverables are achieved.

Internal Stakeholders

• Clinical Research Managers (CRMs)

• Clinical Trial Coordinators (CTCs)

• Clinical Research Associates (CRAs)

• Clinical Operations Managers (COMs)

• Clinical Quality Managers (CQMs)

• Medical Affairs

• Pharmacovigilance

• Regulatory Affairs

• Business Compliance

• Finance

• Legal

• Global and regional functional teams

External Stakeholders

• Investigators

• Clinical trial sites

• Vendors

• Regulatory agencies

• Ethics committees

• Other external partners

Local Process Management

Provide oversight and coordination of:

• Clinical and ancillary supplies management

• Import and export requirements

• Supply destruction processes

• Local filing systems (electronic and hard copy)

• Archiving and retention requirements

• Insurance process management

Maintain and update country information within:

• Clinical systems

• Regulatory systems

• Safety systems

• Financial systems

Experience Required

• Minimum 8 years of clinical research experience.

• Minimum 2 years of people management or team oversight experience.

Core Competencies

Leadership & People Management

• Demonstrated people management skills, including managing teams across countries.

• Ability to influence investigators, vendors, external partners, and country stakeholders.

• Proven ability to deliver commitments within timelines and budget with minimal supervision.

Clinical & Regulatory Expertise

• Strong knowledge of:

  • Budget and contract negotiations

  • Local ethics and regulatory requirements

  • Submission and approval processes

  • Development of local informed consent documents

  • Study start-up and ongoing study deliverables

• Extensive clinical project management experience.

• Expertise in clinical, regulatory, and financial systems, tools, and metrics.

Risk Management & Decision Making

• Ability to identify risks proactively and implement mitigation plans.

• Strong problem-solving capabilities.

• Independent decision-making skills with accountability for outcomes.

Communication & Interpersonal Skills

• Excellent verbal and written communication skills.

• Strong negotiation and influencing capabilities.

• Effective coaching, mentoring, and training skills.

Organizational Effectiveness

• Ability to manage multiple protocols and priorities simultaneously.

• Strong planning, coordination, and organizational skills.

• Ability to work effectively in global and virtual environments.

Language

• Fluency in English and the local language.

Education Required

Bachelor's Degree (or equivalent) in:

• Business Finance

• Business Administration

• Life Sciences

• Healthcare-related discipline

• Equivalent relevant experience

Preferred

Master's Degree (or equivalent) in:

• Business Finance

• Business Administration

• Life Sciences

• Healthcare-related discipline

• Equivalent relevant experience

Team Management Scope

• Direct management of approximately 6–14 employees (COMs and/or CTCs).

• Oversight of contractor COMs and CTCs, where applicable.