Patient Recruitment Specialist
430 East 29th Street New York, New York 10016 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
Patient Recruitment Specialist - pRED
The Patient Recruitment Specialist consults with pRED Clinical Program Leaders (CPLs) and study teams (SMTs) to support the development of effective patient recruitment forecasting strategies. They work within Business Operations Management to support global pRED programs and studies across all therapeutic areas. This individual also participates as an active member in initiatives to design robust methodologies for patient recruitment forecasting and planning and support best practice across pRED. The Patient Recruitment Specialist is an individual contributor role.
- Support data driven decision-making by CPLs during early study and program planning. Collaborate with CPLs to select the best-fit countries to run programs and studies by coordinating and simplifying disease area data, including internal and external benchmarks
- Act as a consultant to CPLs in Molecule / Disease Area recruitment/ retention planning and strategy by providing:
- Recruitment Cycle Time estimates for early planning, Recruitment Scenarios, Country allocations. Study Optimizer is the primary tool used to document the scenarios and projected recruitment cycle times.
- Competitive study landscape assessment, refreshed quarterly, including any key competitive landscape changes to the marketplace for the disease area
- Disease area and country level recruitment rate planning based on available and relevant data
- Support SMTs to develop and refine study level Recruitment and Retention strategy
- Refine cycle times and recruitment rates based on competitive landscape
- Support to finalize study recruitment plan based on country allocations
- Provide potential site information (e.g. current study commitments and metrics)
- Deploy a standard approach to Recruitment Planning for pRED
- Support the adoption and use of a standard recruitment planning process and tools (e.g. Study Optimizer) across pRED studies
- Develop and implement a toolbox repository of standards and metrics
- Support the development and adoption of new tools, tactics and technologies
- Bachelor's degree in science, analytics or biology related field, (Advanced degree and/or certification preferred)
- 6 or more years’ professional experience in the pharmaceutical/ biotechnology industry or related experience (preferably in clinical development, medical affairs, or medical communication agency)
- Relevant work experience with a focus on study planning, ideally including patient recruitment and retention planning and implementation
- Understanding of different recruitment forecasting approaches
- Ability to explore and validate different forecasting methods (real world data sources, statistical algorithms, etc.) and support the development and adoption of new tools, tactics and technologies
- Ability to learn and leverage new tools and analytical sources to drive continuous improvement in early planning
- Ability to readily interpret project and study level requirements (protocol design, inclusion/exclusion criteria, etc.) to support data driven decision-making during early study and program planning, and advise clinical and study teams on potential recruitment scenarios
- Demonstrate expertise in all aspects of the early planning, recruitment and retention process, including risk analysis, strategy and tactic development.
- Strong analytics capabilities and the ability to synthesize complex inputs into recommendations to support data driven decision making
- Ability to drive clear agreements and processes in the absence of agreed best-practices or process standards
- Experience in planning, managing, and coordinating processes or projects. Including designing methods for monitoring the effectiveness and success of new forecasting techniques
- Demonstrate strong understanding of drug development process and how patient and investigator recruitment and retention is part of that process.
- Understanding of the regulatory and logistical processes that affect trial forecasting and planning.
- Demonstrates understanding of HIPAA and ICH/GCP.
- Ability to interact with and influence internal customers effectively (SMTs,CPLs).
- Demonstrates strong communication, collaboration, documentation and follow-up skills.
- Has some familiarity with real world forecasting tools (like TAScan, TrialTrove, etc.) to assess the competitive study landscape and disease prevalence