Remote Feasibility Strategy & Analytics Lead

Pfizer Belgium; Concord (NH); On-site; USD 116,000 - 193,000; Full time

Job summary

Pfizer in the United States seeks a Feasibility Strategic Analytics Lead (Senior Manager) to partner with CSTLs, PR, GSSO, and Clinical Leads. You will deliver rapid, robust feasibility assessments, enrollment assumptions, and site strategy plans to optimize country, site and enrollment footprints.

Expect data-driven scenario planning and cross-functional influence across study teams. The role requires advanced clinical trial feasibility expertise, strong communication, and strategic leadership

Qualifications

• BS / RN / MS & 7 years relevant experience
• PhD / MD and 3 years relevant 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.
• Strong verbal and written communication skills. Effective presentation and facilitation skills.
• Well-developed strategic planning, observation, analytical operational execution and problem-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

Responsibilities

• The FSAL is the OARS 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.
• 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 Op 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 Feasibility Strategy & Analytics Lead (FSAL) will continue to evolve detail on country footprint, enrollment assumptions, and appropriate site classification strategy.
• Support 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.
• Author and maintain 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.
• Analyze results of outreach and evidence to build the recommended country and site strategy.
• Provide 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 classification); ability of site mix to achieve clinical trial diversity goals; competition, site overlap and other key parameters identified as performance drivers by study team.
• Leveraging 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 CD&O teams, and RU/BU partners to improve overall study start up and recruitment cycle time metrics.
• Operational responsibility for delivering to agreed set of KPls 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.

Skills

Strategic analytics

Clinical trial feasibility

Cross-functional collaboration

Data-driven decision making

Stakeholder communication

Education

BS/RN/MS

PhD/MD

Job description

Pfizer in the United States seeks a Feasibility Strategic Analytics Lead (Senior Manager) to partner with CSTLs, PR, GSSO, and Clinical Leads. You will deliver rapid, robust feasibility assessments, enrollment assumptions, and site strategy plans to optimize country, site and enrollment footprints.

Expect data-driven scenario planning and cross-functional influence across study teams. The role requires advanced clinical trial feasibility expertise, strong communication, and strategic leadership