Country & Site Feasibility Lead, FSP

Fortrea•Durham, CA

1d•Remote

About The Position

Fortrea is seeking an experienced Country & Site Feasibility Lead to join their FSP team. This role is remote and US-based, requiring at least 4 years of site feasibility experience. The Global Feasibility Lead will be instrumental in operational strategy and planning within the pre-award phase. This involves contributing to strategy development, conducting thorough primary and secondary data collection and analysis, and creating feasibility and site selection strategies. Additionally, the role entails managing global feasibility projects, collaborating with internal stakeholders to produce comprehensive feasibility reports for clients. The Global Feasibility Lead will facilitate the transition of site selection strategies to the operations team in the post-award phase by transferring relevant pre-award findings. This position also involves leading or contributing to process improvements and change initiatives within Feasibility, as well as providing training on departmental requirements and other relevant topics. The role demands a diverse skill set including strong data mining and analytics, writing and presentation abilities, and customer management skills. Comfort with client-facing interactions, including presenting feasibility findings and recommendations, is essential.

Requirements

BA/BS degree with at least 8 years of executing global drug development programs and trials
Practical experience and understanding of global drug development and clinical trials including demonstrated experience for the mining, manipulating, and presenting of complex scientific data as it relates to clinical research and market analyses.
Minimum of 4 years country and site feasibility experience for global trials using intelligence and other RWD sources
Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives
Must have extensive expertise in strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
Must have experience working across multiple phases of development and in multiple therapeutic areas
Demonstrated ability to successfully identify and lead global process or system improvement initiatives
Must have demonstrated experience developing clinical site relationships and data analysis to predict site performance
Must have proven leadership skills and effective written and verbal communication skills
Fluent in English. Depending on hiring region, may also be required to be fluent in local language.

Nice To Haves

Master or other advanced degree

Responsibilities

Accountable for supporting the development, analyses, interpretation, and presentation of primary and secondary data in support of operational strategy and planning.
Conducts data mining of internal and external databases and initiates/oversees the collection of primary data for use in development of robust strategies for global clinical trials (country/site mix, site selection, enrollment modeling.).
Participates in the development of proposals and bid defenses; provides recommendations on the most appropriate use of data to support proposals and bid defense presentations, works with the team to identify potential risks, and is learning to propose effective solutions as appropriate.
Actively participates on cross-functional teams that plan, analyze, and present proposals and bid defenses as part of winning new business and maintaining client base.
Serves as functional bidder reviewer of the budget and text for proposals for which feasibility and/or site identification is included as the primary deliverable.
Leads cross functional teams in standalone feasibility efforts; responsible for final report creation and delivery, including discussion of findings and recommendations with external clients.
Participates in intra and inter-departmental meetings, leading/contributing to the presentation of information on feasibility offerings, demonstrating continued value-add of the department and providing training on best practices, processes and tools.
Develops networking abilities and has an ability/willingness to work with individuals across the globe.
Leads and/or contributes to process improvement or special projects within Feasibility.
Lead and/or contributes to development, implementation, and maintenance of systems within Feasibility.
Contributes to best practice for feasibility conduct.
Mentors junior team members (GFL1 or newer GFL2s as needed)
And all other duties as needed or assigned.