Instagram
youtube
Facebook

Clinical Operations Manager

5 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ 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 Description

Position Title: Clinical Operations Manager
Requisition ID: R363510


Overview

The Clinical Operations Manager (COM) is accountable for performance, compliance, and oversight of assigned clinical trial protocols within a country, in alignment with ICH/GCP, country regulations, company policies, procedures, and quality standards. This role ensures proper execution of country submissions, approvals, budget/finance aspects, and site readiness, while supporting the delivery of study milestones.


Key Responsibilities

Budget & Finance

  • Full ownership of country and site budgets.

  • Develop, negotiate, and finalize Clinical Trial Research Agreements (CTRA).

  • Track and oversee clinical research-related payments, perform reconciliation at study closeout.

  • Ensure compliance with FCPA, DPS/OFAC, and maintain financial systems.

  • Support financial forecasting in coordination with Sr. COM and other roles.

Regulatory & Compliance

  • Execute and oversee country submissions and approvals for assigned protocols.

  • Prepare and translate local language materials (e.g., Informed Consents).

  • Liaise with IRB/IEC and Regulatory Authorities.

  • Ensure quality, compliance, and adherence to timelines in assigned protocols.

  • Contribute to the development and maintenance of local SOPs.

Operations & Oversight

  • Manage country deliverables, milestones, and results to meet study commitments.

  • Coordinate with CRM, CRA, CTC, Finance, and Legal teams for submissions, budgets, and milestones.

  • Provide oversight and support to local vendors and site staff.

  • Oversee processes related to:

    • Clinical and ancillary supplies management.

    • Import/export requirements and supplies destruction.

    • Filing, archiving, retention, and insurance management.

  • Maintain accurate country data in clinical and finance systems.

Stakeholder Engagement

  • Influence investigators, vendors, external partners, and country teams to ensure delivery.

  • Collaborate with global headquarters, regional operations, and cross-functional teams.

  • Act as a Subject Matter Expert (SME) for processes, sharing best practices and training others.

  • Mentor and support CTCs, contributing to knowledge building within the COM team.

Continuous Improvement & Initiatives

  • Contribute or lead local and global initiatives/projects.

  • Proactively develop risk management and mitigation strategies.

  • Recommend process improvements to enhance efficiency and compliance.


Core Competencies

  • Expertise in clinical systems, tools, and metrics.

  • Strong knowledge of budget and contract negotiations.

  • In-depth understanding of local regulatory environment, submission, and approval processes.

  • Excellent coordination, organizational, and influencing skills.

  • Ability to work independently, make decisions, and resolve issues with minimal oversight.

  • Skilled in mentoring, training, and knowledge-sharing.


Behavioral Expectations

  • Strong problem-solving and root cause analysis skills.

  • Effective time management, prioritization, and interpersonal skills.

  • High accountability and urgency to deliver against commitments.

  • Strong communication, leadership, and negotiation skills in both English and local language.

  • Ability to manage multiple deliverables and protocols simultaneously.

  • Positive, growth-oriented mindset; self-driven and independent.


Qualifications

Education

  • Required: Bachelor’s degree in Business Finance, Administration, Life Sciences, or equivalent healthcare-related field.

Experience

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


Additional Information

  • Employee Status: Regular

  • Relocation: Not Applicable

  • VISA Sponsorship: Not Available

  • Travel Requirements: As applicable

  • Flexible Work Arrangements: Not Applicable

  • Shift: Standard business hours

  • Valid Driving License: May be required

  • Hazardous Materials: Not applicable


Skills

Required

  • Adaptability

  • Clinical Operations & Research

  • Clinical Site & Trial Management

  • Clinical Trial Agreements & Compliance

  • Documentation & Planning

  • Financial Administration & Forecasting

  • Insurance & Risk Management

  • ICH GCP Guidelines

  • Patient Recruitment

  • Problem-Solving

Preferred

  • Cross-cultural awareness

  • Customer experience management

  • Economic forecasting

  • Process management


Job Posting Information

  • Job Posting End Date: September 30, 2025
    (Applications must be submitted no later than 11:59:59 PM on the day before the listed end date.)