Senior Clinical Feasibility Leader at PAREXEL

• This is an exciting client- facing opportunity, you will be the senior functional leader assigned as part of the core project team, responsible to drive all feasibility and site identification activities immediately after award on all types and phases of studies . We are looking for candidates who can deliver optimized operational strategies, based on selection of countries and clinical sites best positioned to successfully execute the trials within their projects. Excellent communication and leadership skills are essential within this role to support client interactions and long term strategic partnerships internally and externally. Strong analytical skills are a necessity to fully adopt a consistent data-driven approach to feasibility and site identification.

Deliverables In The Role

• Through in-depth review of protocol design, competing landscape, and recruitment benchmark data, conduct initial protocol feasibility assessment or revise pre-award protocol feasibility assessment taking into account new data received/collected after award via standard and nonstandard sources of information as appropriate.
• Conduct initial country selection analysis or adjust preaward country selection analysis via available country selection tool/platform based on new data received/collected after award using standard and nonstandard sources of information as appropriate and deliver protocol-specific country recommendations including solid data-driven rational.
• Advise on the specific augmented services tailored to the protocol, conduct standard augmented feasibility services defined as Key Opinion Leader (KOL) interviews, Electronic Health Record (EHR) protocol assessments, investigator outreach, and patient feasibility surveys in accordance with departmental guidelines and relevant Standard Operational Procedures (SOP), as well as lead pilots for innovative feasibility approaches.
• Lead the development of an integrated operational strategy to successfully recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy utilizing available modeling tools and techniques.
• Articulate and defend the proposed country and site selection strategy and enrolment scenario models in PAREXEL internal meetings and Sponsor meetings, as well as present PAREXEL feasibility approach and processes in Sponsor capability meetings or audits.
• Independently 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, project management, including milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, production of key project progress reports, and management of communication between PAREXEL project team, Sponsor, contract and financial management.
• Provide oversight and support pre-award activity when needed.
• Attend Bid Defense Meetings and/or Sponsor Kick-Off meetings for any projects as per management needs and present feasibility pre-award data as well as post-award feasibility/pre-qualification services, processes, and timelines.

You Will Need

• Educated to at least Bachelor of Science level or Bachelor of Science in Nursing, Masters, MD, PhD
• Relevant clinical research experience in management of international clinical trials
• Demonstrated expertise of feasibility requirements
• Previous exposure to development of clinical trial strategy, modeling of enrollment scenarios, and selection of country/sites
• Fluent in written and spoken English.
• Extensive prioritization skills; must be able to resolve conflicting priorities to meet tight deadlines while maintaining quality and attention to details
• Demonstrated leadership and mentoring capabilities, and ability to influence others
• Creative problem-solving skills, which supports client-focused approach to work