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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. 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, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations. The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Essential Job Duties:
FINANCIAL :
• Ownership of country and site budgets.
• Development, negotiation and execution of Clinical Trial Research Agreements (CTRA).
• 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.
• Oversight of FCPA, Denied Parties Screening and maintenance of financial systems.
• Financial forecasting and tracking of operational budget in conjunction with the client manager.
• Deliver the expertise in country based regulations, laws and procedures
• Provide an oversight and tracking of clinical research-related payments
• Familiar with the National Contract Value Review known as NCVR and ICT
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.
• May oversee contract workers and local vendors as applicable.
COLLABORATION:
• Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, budgets, CTRAs and local milestones.
• Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. 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, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations. The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Essential Job Duties:
FINANCIAL :
• Ownership of country and site budgets.
• Development, negotiation and execution of Clinical Trial Research Agreements (CTRA).
• 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.
• Oversight of FCPA, Denied Parties Screening and maintenance of financial systems.
• Financial forecasting and tracking of operational budget in conjunction with the client manager.
• Deliver the expertise in country based regulations, laws and procedures
• Provide an oversight and tracking of clinical research-related payments
• Familiar with the National Contract Value Review known as NCVR and ICT
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.
• May oversee contract workers and local vendors as applicable.
COLLABORATION:
• Works in close collaboration internally with Clinical country operations (CRD, CRM,CTC,CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, budgets, CTRAs and local milestones.
• Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.