Clinical Operations Manager

Fortrea

. Execute and oversee local operational clinical trial activities at the country level .

Posted 9/17/2026full-timeRemote • United StatesMid-LevelSenior💰 $100,000 - $113,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial operations, regulatory compliance, and financial oversight while ensuring adherence to ICH Guidelines and GCP. Proficient in developing local-language materials and collaborating with diverse stakeholders to achieve trial objectives.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory ComplianceICH Guidelines KnowledgeBudget ManagementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory SubmissionsBudget ReconciliationRisk ManagementInformed Consent DevelopmentDrug Development ProcessInvestigator Start-Up DocumentsClinical Research OperationsGCP KnowledgeLocal Regulatory Requirements

Soft Skills

LeadershipDetail-OrientedMulti-TaskingAdaptabilityTeam Collaboration

Tools & Technologies

Clinical SystemsRegulatory SystemsSafety SystemsFinance SystemsComputer Packages

Certifications & Qualifications

University Degree in Life ScienceNursing CertificationMedical Technology Certification

Industry Keywords

Pharmaceutical IndustryCRO IndustryIRB/IECFDA RegulationsHealth Care Setting

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Execute and oversee local operational clinical trial activities at the country level
Own and oversee local regulatory and financial compliance
Deliver country-specific trial commitments and objectives, especially during study start-up
Influence investigators, vendors, external partners, and country managers to deliver commitments
Adhere to budget targets and payment timelines
Address and resolve issues and develop country risk management and mitigation plans
Manage country and site budgets and clinical research-related payments
Reconcile payments at study close-out
Execute and oversee country submissions and approvals for assigned protocols
Develop local-language materials, including informed consents and translations
Work with IRB/IEC and Regulatory Authorities on submission and approval interactions
Manage country deliverables, timelines, and results for assigned protocols
Contribute to local SOP development
Collaborate with clinical operations, quality, finance, medical, regulatory, pharmacovigilance, compliance, legal, regional operations, vendors, sites, IRBs/IECs, and Regulatory Authorities
Align country timelines with Regional Operations and oversee local vendors
Oversee clinical and ancillary supplies, importing/exporting, supplies destruction, filing, archiving, retention, and insurance processes
Enter and update country information in clinical, regulatory, safety, and finance systems
Perform other duties as assigned

Requirements

What you’ll need

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
Relevant and equivalent experience may be considered in lieu of educational requirements
Minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting may substitute for the educational requirement
Thorough knowledge of ICH Guidelines and GCP
Basic understanding of regulatory requirements in other countries
Thorough understanding of the drug development process
Fluent in local office language and English, written and verbal
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines
Familiarity with investigator start-up documents
Previous interaction with operational project teams and investigative sites preferred
Excellent oral and written communication skills
Good computer skills and working knowledge of a range of computer packages
Ability to lead and develop junior staff
Minimum of four-six (4-6) years of clinical research experience
Ability to work independently and in a team environment, under pressure, and meet deadlines
Detail- and process-oriented
Multi-tasking capability
Flexible and adaptable to a developing work environment

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short-term disability (STD) and long-term disability (LTD)
401(K)
Employee Stock Purchase Plan (ESPP)
Paid time off (PTO) or Flexible time off (FTO)
Company bonus where applicable