Country & Site Feasibility Lead, FSP

Job Overview:

The Global Feasibility Lead will play an integral role in operational strategy and planning in the preaward space through participation in strategy development conversations, robust primary and secondary data collection and analysis, and development of feasibility and site selection strategies. In addition, the Global Feasibility Lead 2 will be responsible for managing global feasibility projects, working closely with representatives within the company to deliver robust feasibility reports to our customers. The Global Feasibility Lead 2 will transition the site selection strategy to operations in the post-award space by handing over relevant pre-award findings to the site selection team. The Global Feasibility Lead 2 will lead and/or contribute to process improvement and change initiatives within Feasibility, alongside training opportunities for departmental requirements and any other subjects that impact on feasibility conduct. The Global Feasibility Lead 2 role requires a diverse skill set; strong data mining and analytics skills, writing and presentation skills, and customer management skills are required. Comfort with participating in and/or leading client facing interactions as it relates to presenting feasibility related findings and recommendations is necessary.

Summary of 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.

Qualifications (Minimum Required):

• 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.

Experience (Minimum Required):

• 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. 
• Minimal (~10%) travel required

Preferred Qualifications Include:

• Master or other advanced degree

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

• Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

#LI - Remote

Applications will be accepted on an ongoing basis.

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