As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview: Accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client.
The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must.
This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, and maintaining expertise in country-based regulations, laws, and procedures with minimal support from the client management.
Requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Summary of Responsibilities: FINANCIAL (as applicable): Assistance with the ownership of country and site budgets.
Through continual interaction with local clinical team/s, successfully delivers clinical and financial contracts within fair market value.
Oversight and tracking of clinical research-related payments.
Payment reconciliation at study close-out.
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable): Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Development of local language materials including local language Informed Consents and translations.
Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.
MANAGEMENT & QUALITY OVERSIGHT: Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.
Contributes to the development of local SOPs.
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