Clinical Operations Manager (COM)

Fortrea · Durham, NC

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Clinical OperationsFull timeCompany career page

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Role summary

Fortrea seeks a Clinical Operations Manager to oversee clinical trial execution, regulatory compliance, and financial management at the country level. The role requires managing budgets, coordinating submissions, and collaborating across internal and external stakeholders to meet trial commitments.

What they're looking for

Bachelor's degree in life sciences or equivalent healthcare certification; 4+ years clinical research experience in pharma/CRO or healthcare
Thorough knowledge of ICH Guidelines, GCP, FDA, and local regulatory requirements
Fluent in local office language and English, both written and verbal
Strong organizational, time management, and detail-oriented skills
Excellent communication and interpersonal abilities; ability to work independently and in teams
Computer proficiency and familiarity with clinical, regulatory, and finance systems
Capability to lead junior staff and adapt to evolving environments

What you'll be doing

Own country and site budgets, negotiate clinical and financial contracts, track payments, and reconcile at study close-out
Execute country submissions, develop local language materials including informed consents, and coordinate with IRB/IEC and regulatory authorities
Manage country deliverables, timelines, and quality oversight; contribute to local standard operating procedures
Collaborate with internal teams and external vendors, sites, and regulatory bodies to ensure compliance and milestone achievement
Oversee clinical and ancillary supplies management, archiving, filing requirements, and system data entry

Compensation$100,000-$113,000 USD

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Date posted1 day ago

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