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Clinical Operations Manager

Msd
MSD
5+ years
Not Disclosed
10 Jan. 19, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Operations Manager | Merck & Co., Inc.

Location: Europe, Middle East, Africa, Latin America & Asia Pacific (Residency-based)
Job Reference: R363510
Experience Required: 5+ years
Education Required: Bachelor’s degree in Business, Finance, Administration, Life Sciences, or relevant Healthcare field
Job Type: Regular


About Merck & Co., Inc.

Merck & Co., Inc., also known as Merck Sharp & Dohme LLC in the USA, is a global biopharmaceutical leader dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. The company operates across multiple regions with a strong focus on ethics, compliance, and scientific innovation.


Role Overview

The Clinical Operations Manager is accountable for the performance, compliance, and financial management of assigned clinical trial protocols in a country. This includes oversight of regulatory submissions, approvals, site readiness, and compliance with ICH/GCP standards, local regulations, and internal company policies.

The role ensures effective coordination across cross-functional teams, manages country and site budgets, and supports clinical trial execution from start-up through closeout.


Key Responsibilities

Clinical Trial Management & Compliance

  • Manage and execute country-specific clinical trial submissions and approvals.

  • Develop local language materials, including Informed Consent Forms and translations.

  • Ensure adherence to quality standards, adverse event reporting, and GCP/ICH regulations.

  • Contribute to the development of local SOPs and oversee local Clinical Trial Coordinators (CTCs).

  • Coordinate with CRM, CTC, CRA, Finance, Legal, and Headquarters to align country deliverables, timelines, budgets, and contract agreements.

Financial Oversight

  • Own country and site budgets, including Clinical Trial Research Agreements (CTRAs) and payment reconciliation at study closeout.

  • Manage clinical research-related payments and financial systems, ensuring compliance with FCPA, DPS/OFAC, and company policies.

  • Collaborate on financial forecasting in conjunction with senior Clinical Operations Managers (Sr.COM).

Vendor & Stakeholder Management

  • Support and oversee local vendors and investigative sites, ensuring timely delivery of milestones.

  • Liaise with IRBs/IECs, Regulatory Authorities, and external partners to achieve study objectives.

  • Influence investigators, vendors, and country teams to address operational or compliance issues.

Operational Leadership

  • Oversee local processes, including clinical and ancillary supplies, import/export, archiving, insurance, and system updates.

  • Act as a subject matter expert (SME), sharing best practices, training, and mentoring other country operations staff.

  • Develop and implement risk management and mitigation plans proactively to prevent delays or non-compliance.


Core Competencies & Skills

  • Expertise in clinical systems, tools, and metrics.

  • Strong budgeting, contract negotiation, and regulatory compliance knowledge.

  • Excellent coordination, organizational, and communication skills in English and local language.

  • Proven ability to influence and resolve issues independently with investigators, vendors, and stakeholders.

  • Ability to manage multiple deliverables and protocols simultaneously, including in virtual environments.

  • High accountability, problem-solving skills, and proactive decision-making.

Preferred Skills

  • Knowledge of clinical operations processes and cross-cultural awareness.

  • Experience in patient recruitment, clinical site management, and clinical trial planning.

  • Familiarity with ICH/GCP guidelines, financial forecasting, and insurance risk management.


Experience & Education Requirements

  • Required: 5+ years of combined experience in clinical research and/or finance/business operations.

  • Education: Bachelor’s degree in Business, Finance, Administration, Life Sciences, or related Healthcare field.


Work Environment

  • Flexible work arrangements depending on region.

  • Ability to work in multi-country, cross-cultural settings.

  • Strong focus on collaboration, accountability, and delivering country-specific trial commitments.


Additional Information

  • Minimal travel may be required.

  • This posting is valid for applications until January 30, 2026.

  • Merck does not accept unsolicited agency resumes without a valid search agreement.