Clinical Feasibility Leader

Site Identification

• Develop and implement protocol-specific site identification strategy to produce initial lists of sites as per departmental quality standards.
• Using the standard template, design a protocol-specific site questionnaire based on the available study information, the Sponsor questionnaire (if any), and agreed site selection criteria that will enable an in-depth analysis of the responses and will highlight the protocol challenges as viewed by the investigators as well as enable the selection of most appropriate sites.
• Lead the team of locally assigned individuals to successfully deliver prequalified sites including but not limited to provide initial training on the study protocol and specifics during survey kick-off meeting, officially launch the survey via the standard initiation email, and resolve resourcing/performance issues via standard escalation paths. Stand as accountable for survey completion within the agreed timelines.
• Deliver revised enrolment scenario and final list of pre-qualified sites following quality review of investigator responses, identification and clarification of inconsistencies, recommendations against agreed site selection criteria, and analysis of recruitment capabilities.
• Develop comprehensive slide deck and/or integrated report to present the outcome of the site selection process including methodology, high level results, and recommendations inclusive of adjustments to scenario models as needed.

Country Selection

• Revise pre-award protocol feasibility assessment taking into account new data received/collected after award via standard sources of information.
• Adjust pre-award country selection analysis via available country selection tool/platform based on new data received/collected after award using standard sources of information and deliver protocol-specific country recommendations including solid data-driven rationale.
• Independently manage country clinical operations survey including collection and review of country data, follow-up discussions with local clinical operations representative, and compilation of collected information into country selection analysis, scenario modeling, and site identification strategy.
• Contribute to the development of an integrated optimized operational strategy to successfully recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy utilizing available modeling tools and techniques.
• Develop comprehensive slide deck and/or integrated report to present the outcome of the country selection analysis including methodology, high level results, and recommendations.
• Articulate and defend the proposed country and site selection strategy and enrolment scenario models in PAREXEL internal meetings and Sponsor meetings.

Miscellaneous

• Under management supervision, act as Project Leader on stand-alone feasibility studies, which includes the following additional responsibilities: Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, production of key project progress reports, management of communication between PAREXEL project team, Sponsor, contract and financial management.
• Attend Bid Defense Meetings and/or Sponsor Kick-Off Meetings for projects as named CFL and present post-award feasibility/prequalification services, processes, and timelines.
• Serves as Subject Matter Expert (SME) for an identified feasibility system, tool, or process.

Knowledge and Experience:

• Relevant clinical research experience in management of international clinical trials; feasibility and recruitment
• Demonstrated clear understanding of country and site feasibility requirements.
• Previous exposure to development of clinical trial strategy, modeling of enrollment scenarios, and selection of country/sites