Clinical Feasibility Leader

Parexel

3d•Remote

About The Position

Parexel is seeking a home-based Clinical Feasibility Leader (CFL) from select EMEA locations. The CFL serves as the functional lead on the core project team for site identification activities immediately after study award, across study types and phases. Working independently with limited management supervision, the CFL develops an optimized operational strategy by selecting countries and clinical sites best positioned to execute the trial. The role requires strong communication and leadership, strategic thinking, and analytical skills to deliver quality outputs on time using a consistent, data-driven approach to site identification. The CFL develops protocol-specific site identification strategies and questionnaires, leads locally assigned teams through site surveys, reviews investigator responses, assesses recruitment capabilities, and delivers revised enrollment scenarios and lists of pre-qualified sites. The role also updates country feasibility assessments and selection analyses using available data and tools, manages country operations surveys, contributes to integrated recruitment strategies, and presents and defends country and site recommendations and enrollment scenarios to internal teams and Sponsors. Under management supervision, the CFL may also lead stand-alone feasibility studies, including Sponsor liaison, project assessment and initiation, resource planning, implementation, milestone tracking, progress reporting, and coordination of communications among project teams, Sponsors, and contract and financial management. The CFL may attend bid defense or Sponsor kick-off meetings to present feasibility services and serve as a subject matter expert for an identified feasibility system, tool, or process.

Requirements

Relevant clinical research experience in management of international clinical trials, feasibility, and recruitment.
Clear understanding of country and site feasibility requirements.
Previous exposure to clinical trial strategy development, enrollment scenario modeling, and country/site selection.
Strong strategic thinking and analytical skills applied to business needs.
Excellent interpersonal, verbal, and written communication skills.
Demonstrated leadership and ability to influence others.
Problem-solving skills and a client-focused approach to work.
Flexible attitude toward work assignments and new learning.
Ability to prioritize workload and attend to detail.
Willingness to work in a matrix environment and value teamwork.
Ability to work independently and in a decentralized reporting model, as applicable.
Fluent written and spoken English.

Nice To Haves

Preferred degrees may include a Bachelor of Science, Bachelor of Science in Nursing, master's degree, MD, PhD, or comparable life-skill experience.

Responsibilities

Develop and implement protocol-specific site identification strategies and initial site lists in line with departmental quality standards.
Design protocol-specific site questionnaires using available study information, Sponsor questionnaires, and agreed site-selection criteria.
Lead locally assigned team members in delivering pre-qualified sites, including providing study-specific training, launching surveys, resolving resourcing or performance issues through escalation paths, and ensuring survey completion on time.
Review investigator responses for quality, clarify inconsistencies, apply agreed site-selection criteria, analyze recruitment capabilities, and deliver revised enrollment scenarios and final lists of pre-qualified sites.
Prepare slide decks or integrated reports describing site-selection methodology, results, and recommendations, including scenario-model adjustments as needed.
Revise pre-award protocol feasibility assessments using new data collected or received after award.
Update country-selection analyses using available tools and new data, and provide protocol-specific country recommendations with data-driven rationale.
Manage country clinical operations surveys, including collecting and reviewing country data, following up with local clinical operations representatives, and incorporating findings into country-selection analysis, scenario modeling, and site-identification strategy.
Contribute to an integrated operational strategy for patient recruitment and develop enrollment scenarios aligned with the agreed strategy using available modeling tools and techniques.
Prepare slide decks or integrated reports presenting country-selection methodology, results, and recommendations.
Present and defend country and site-selection strategies and enrollment scenario models in Parexel internal and Sponsor meetings.
Under management supervision, act as Project Leader on stand-alone feasibility studies, covering Sponsor liaison, project assessment and initiation, resource procurement and planning, implementation, milestone planning and tracking, progress and quality oversight, progress reporting, and project communications.
Attend bid defense and/or Sponsor kick-off meetings as the named CFL and present post-award feasibility and prequalification services, processes, and timelines.
Serve as a subject matter expert for an identified feasibility system, tool, or process.