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Clinical Feasibility Leader
Contract type
Ongoing
Work mode
Remote · select EMEA locations
Experience
3 years
Job description
The Clinical Feasibility Leader (CFL) is a functional lead in the core project team who drives site identification activities after study award across all study types and phases. The role delivers data-driven country and site selection strategies and enrolment scenarios for clinical trials.
At a glance
- Work mode
- Remote · select EMEA locations
- Languages
- English – fluent
What you'll do
- Develop and implement protocol-specific site identification strategy to produce initial lists of sites as per departmental quality standards
- Design a protocol-specific site questionnaire based on available study information, the Sponsor questionnaire (if any), and agreed site selection criteria
- Lead the team of locally assigned individuals to successfully deliver prequalified sites, including initial training on the study protocol during survey kick-off meeting, launching the survey via the standard initiation email, and resolving resourcing/performance issues via standard escalation paths
- 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
- Revise pre-award protocol feasibility assessment taking into account new data received/collected after award
- Adjust pre-award country selection analysis via available country selection tool/platform based on new data and deliver protocol-specific country recommendations with 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 recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy
- Articulate and defend the proposed country and site selection strategy and enrolment scenario models in internal and Sponsor meetings
- Act as Project Leader on stand-alone feasibility studies under management supervision, including Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, milestone planning and tracking, project progress reports, and communication 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
- Serve as Subject Matter Expert (SME) for an identified feasibility system, tool, or process
What we're looking for
- 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
- Strong strategic thinking and analytical skills applied to business needs
- Excellent interpersonal, verbal and written communication
- Demonstrated leadership and ability to influence others
- Problem-solving skills allowing Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to prioritize workload with attention to details
- Willingness to work in a matrix environment and to value the importance of teamwork
- Ability to work independently and in a decentralized reporting model
- Fluent in written and spoken English
Apply
About Parexel
When our values align, there's no limit to what we can achieve.
Parexel provides clinical trials, regulatory, consulting, and market access solutions; every clinical development solution is underpinned by a deep conviction in what they do.
Mission
To improve the world's health.
Key facts
- Each employee contributes to the development of a therapy that ultimately will benefit a patient
- Work is taken personally, done with empathy, and committed to making a difference
What they value
- Empathy
- Commitment to making a difference