Capitalize on the foundation of knowledge in the areas of Pfizer historic study performance data, competitor trial performance, real world data, and industry benchmarks using a variety of analytic and modeling tools such as DecisionView StudyOptimizer (DVSO). Provide Feasibility Leads with timely up-to-date information and intelligence on decision making data elements in support of the OpCo governance process. Support the development of more consistent and accurate study timeline and enrollment projections that drive study team decision making and enhance predictable delivery of the portfolio.
- Support Feasibility Leads in establishing data driven enrollment projections throughout the development lifecycle from asset planning through study initiation to completion of study enrollment
- Analyze internal and/or external enrollment data from appropriate reference studies establishing a range of enrollment rates utilized in scenario development
- Provide DVSO Subject Matter Expertise and training to Feasibility Leads, study teams, CD&O and CRO stakeholders. Ensure consistent utilization of DVSO for enrollment planning and reporting
- Drive proactive risk mitigation through data driven enrollment scenarios utilizing internal and external data sources
- Ensure effective scenario generation and planning comparing Pfizer’s past performance data and proposed scenarios from CROs
- Optimize enrollment scenarios for speed, country footprint and number of centers to meet study objectives
- Ensure data driven enrollment scenarios are presented in a standardized format
- Maintain relationships with providers/vendors of innovative capabilities in feasibility, scenario planning and protocol optimization
- Routinely review enrollment plans of ongoing studies in support of CD&O and portfolio priorities
- Participate in the establishment of systems and processes that support early feasibility by leveraging existing data sources and organizational knowledge/expertise
- Responsibility for the establishment and delivery of feasibility analytics and metrics against an agreed upon set of KPIs/goals
- Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies supporting Study Optimization feasibility analytics and early planning
- Maintain connectivity to Pfizer portfolio and clinical trial pipeline to ensure information and intelligence on indications of interest are available in a timely manner.
- Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
QUALIFICATIONS / SKILLS
- A broad based experience clinical research is preferred, Knowledge of GCP and a good understanding of the processesassociated with study start up, feasibility and enrollment planning.
- History of success in a customer service role with demonstration of meeting customer expectations.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
- Knowledge of drug development, a thorough understanding of the processesassociated with feasibility, clinical study start-up and business operations
- In general, candidates for this job would have the following levels of experience:
- BS/RN – 8 years
- MS - 6 years
- PhD/MD – 3 years
EEO & Employment Eligibility