Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Operations Manager

Msd
MSD
5+ years
Not Disclosed
10 Jan. 22, 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

Job Title: Clinical Operations Manager
Location: Europe, Middle East, Africa, Latin America & Asia Pacific
Employment Type: Full-time, Regular
Application Deadline: January 30, 2026
Requisition ID: R363510


About the Role

The Clinical Operations Manager (COM) ensures high-quality and compliant execution of clinical trials at the country level. This role is accountable for performance, regulatory compliance, financial management, and site readiness for assigned protocols. Reporting to the Line Manager, you will lead cross-functional collaboration with internal teams, investigators, vendors, and regulatory authorities to meet study objectives efficiently.


Key Responsibilities

  • Manage country and site budgets, oversee clinical trial payments, and reconcile finances at study closeout.

  • Negotiate, develop, and execute Clinical Trial Research Agreements (CTRA) in compliance with FCPA, DPS/OFAC, and internal financial policies.

  • Lead submissions and approvals for clinical trial protocols, including development of local-language materials, informed consent documents, and translations.

  • Maintain regulatory compliance and ensure adherence to ICH/GCP, local regulations, and internal SOPs.

  • Oversee local processes including clinical and ancillary supply management, import/export requirements, data filing, archiving, and insurance management.

  • Collaborate with CRM, CTC, CRA, Finance, Legal, and HQ teams to align country timelines and deliverables.

  • Provide oversight and guidance to local vendors and clinical trial coordinators (CTCs).

  • Act as a Subject Matter Expert (SME) for country operations processes, mentoring colleagues, sharing best practices, and driving continuous improvement initiatives.

  • Proactively manage risk, develop mitigation strategies, and resolve operational or regulatory issues locally.


Core Competencies

  • Expertise in clinical systems, tools, and metrics

  • Strong coordination, organizational, and project management skills

  • Financial and budget management knowledge, including CTRA negotiations

  • Regulatory awareness and ability to influence investigators, vendors, and partners

  • Excellent written and verbal communication, leadership, and mentoring skills

  • Ability to manage multiple protocols simultaneously and work effectively in virtual environments


Required Qualifications

  • Bachelor’s degree in Business, Finance, Administration, Life Sciences, or related healthcare field

  • Minimum 5 years of experience in clinical research or a combination of clinical research and finance/business operations

  • Proven ability to manage budgets, contracts, regulatory submissions, and country-level clinical operations


Behavioral Expectations

  • Strong problem-solving and conflict-resolution skills

  • High accountability, initiative, and self-driven mindset

  • Ability to work independently and influence cross-functional stakeholders

  • Positive and growth-oriented mindset with adaptability to changing priorities


This role is a strategic position ideal for professionals seeking to lead clinical trial operations at the country level while contributing to global clinical research excellence.