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.
In this role you are accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Fortrea’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. You would be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Essential Job Duties

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees maintenance of financial systems.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Coordinates and liaises with PM/CTL/CTA and CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Provides support and oversight to local vendors as applicable.
• Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
• Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.

Experience

• Strong experience in clinical research or combined experience in Clinical Research and Finance/Business
• Strong coordination and organizational skills
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission in EUCTR and approval processes, and understanding of how these impact study start-up.
• Expertise of core clinical systems, tools and metrics
• Excellent English skills
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
• Requires strong understanding of local regulatory environment
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Education

• Bachelor’s Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

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• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees maintenance of financial systems.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Coordinates and liaises with PM/CTL/CTA and CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Provides support and oversight to local vendors as applicable.
• Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
• Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines