The Feasibility Strategy & Analytics Lead (FSAL) is responsible for partnering with Clinical Study Team Lead (CSTL), Participant Recruitment (PR), Global Site & Study Operations (GSSO) roles, and Clinical Leads to enable the predictable delivery of Client’s portfolio by providing rapid, accurate and robust assessments of program and protocol feasibility, recruitment enrollment assumptions, and site strategy plans.

Key Accountabilities:

Operations Support

• Provides the study team with robust scenario planning to inform and finalize an optimized country, site, and study enrollment plan by leveraging data driven estimates, benchmarking assumptions, competitive intelligence, indication level knowledge, internal and external data sources, and the site predictability engine

• Drives country and site selection for Pre Trial-Assessment (PTA) for the study plan and leads the delivery of sites endorsed for PTA for the study through the planning of the optimal country and site footprint taking into consideration site segmentation strategies

• Provides the study team recommendations on country and site selection, develops ideas to bridge the gap between evidence driven assumptions and 3x3 recruitment goals and has advanced knowledge in the field of country and site strategy and feasibility

• Is the Operational Analytics & Quantitative Services (OAQS) single point of contact for the study team in the build of evidence driven study assumptions to provide a country and site strategy that includes a list of proposed countries and sites to be targeted during site feasibility/selection, enrollment scenarios, and protocol optimization strategies. FSAL will continue to support study team enrollment to assess future changes to that strategy (e.g., plan adjustments or re-baseline) through the completion of participant recruitment

• Implements processes related to country & site intelligence and provide continuity by connecting and documenting changes throughout the lifecycle (from early estimates, early feasibility, detailed assumptions, detailed feasibility, to participant recruitment, study start-up planning and last subject first visit)

• Provides early feasibility (before core protocol elements are available) by providing initial enrollment timelines, potential country footprint, primary intelligence gathering (benchmark studies, competitive landscape, treatment approvals etc.), and key enrollment assumptions to inform initial high-level Operations Plan assumptions

• Introduces opportunities for protocol optimization by leveraging real world data, investigator insights, patient insights, protocol simulations, and coordinates with relevant functions to incorporate these insights in study assumptions

• As protocol elements evolve to final protocol and start up stages, the FSAL will continue to evolve detail on country footprint, enrollment assumptions, and appropriate site segmentation strategy

• Supports the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinate global efforts for site intelligence

• Authors and maintains oversight of both Country and Site Feasibility outreach and engagement, lead response reviews with appropriate study team members, and provide strategic input into team decision making

• Analyzes results of outreach and evidence to build the recommended country and site strategy

• Provides summary site analytics as the volume of sites is progressed through evaluation stages to PTA to ultimate Site Selection. Analytics include modeling volume of patients (by site segmentation); ability of site mix to achieve clinical trial diversity goals; competition, site overlap and other key parameters identified as performance drivers by study team

• Leverages the totality of data available (internal, external and regional intelligence), provide strategic scenarios based upon team input and request, to team on options and levers to optimize site footprint and enrollment timelines

• Partners with Clinical Development & Operations (CDO) teams, and Research Unit/Business Unit partners to improve overall study start up and recruitment cycle time metrics

• Operational responsibility for delivering to agreed set of Key Performance Indicators (KPIs) for assigned protocols

• Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity through uptake of innovative strategies

• Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies

• Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery

Compliance with Parexel standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH- GCPs and other applicable requirements

Skills:

• Fluency in written and spoken English required

• Strong verbal and written communication skills. Effective presentation and facilitation skills

• Well-developed strategic planning, observation, analytical operational execution, and 1] solving skills

• Strong business consultancy skills, including ability to persuade, negotiate, and moderate conflict

• Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high-quality work

• Able to synthesize key messages pulling across multiple data sets

Preferred Qualifications:

• Experience in operations involving multinational clinical trials

• Prior experience in global country and site feasibility

• Able to make complex decisions that require assessing and choosing amongst multiple options, amidst competing priorities, and in ambiguous situations, to timelines and with available resource

• Conversant with the long-term strategy of the business and can leverage this to prioritize activities and answer key business questions

Knowledge and Experience:

• Knowledge of Drug development, a thorough understanding of the processes associated with global country and site feasibility, clinical study start-up and business operations

• Experience in clinical research, including clinical trial conduct, knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations

• History of success in a customer service role with demonstration of meeting customer expectations

Education:

• Bachelor of Science (BS), Registered Nurse (RN), or Master of Science (MS) and 7 years relevant experience

• Doctor of Philosophy (PhD) or Doctor of Medicine (MD) and 3 years relevant experience