Associate Feasibility Manager

Develops relationships with internal departments to conduct and ensure delivery of high-quality feasibility/site identification assessments. Expertise in region with regard to Standard of Care, disease landscape and competitive intelligence including but not limited to competing trials, recent or upcoming approvals, prescribing data, insurance claims data, and recruitment capabilities. This includes conducting feasibility outreach and participating in intelligence gathering and risk assessment to coordinate feasibility projects and deliverables. Aligned within global feasibility and the site management team, this position will play a critical role in data-driven strategic design and operational feasibility, site identification and recruitment and retention recommendations for early to late-stage medicines development across global clinical operations (GCO), beginning at the concept stage through to execution.

The Associate Feasibility Manager with oversight from the Functional Manager provide in-depth regional review and engagement cross-departmentally to determine and inform on region’s capabilities to conduct protocols and successfully meet/exceed targeted enrollment. Supports the Feasibility team with successful delivery of allocated feasibility studies according to timeline, quality standards and BeiGene expectations for all phase study type awards.

Essential Functions of the job:

• In partnership with internal stakeholders including regional leaders (e.g., country heads, regional study managers) and site management (e.g., CRAs, trial oversight managers) -combines and integrates data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution.
• Provide data-driven operational feasibility strategy, including site identification, and recruitment and retention recommendations at TA/indication/program level taking into consideration outstanding needs of indication, patient population, study, and business priorities.
• Collect and analyze all data (e.g., local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and establish a geographic country footprint and proposed sites for participation in a clinical study.
• Use all competitive intelligence data to develop data-driven study startup forecasts, benchmarking assumptions, and accurate enrollment plans.
• Develop deep insights, uncover unmet needs, collaborate within a global matrixed team
• Explain data and facilitate decision-making processes to be data driven.
• Partners with study design teams on protocol optimization enabling data-driven approaches to inform decision making and improve predictability of execution
• Contribute in efforts to implement creative processes, methodologies, data, and technologies to ensure ongoing delivery of valued Feasibility and Study Startup Services. Contributes to Strategic planning meetings, regional in-depth capabilities meetings, training calls, kick off meetings and ongoing team meetings to confirm adequacy of sites/enrollment and ongoing feasibility support.
• Leverage leading industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, startup cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting.
• Maintain the patient enrollment forecast from a strategic perspective. In collaboration with the BeiGene study team and CRO (if applicable), responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g., change in drug landscape, protocol amendment, increased screen failure rate).
• Lead study-specific recruitment programs working closely with the clinical study teams, vendors, and CRO as applicable.
• Determine risk/ mitigation planning to study feasibility or recruitment of the study participants.
• Maintain current therapeutic area knowledge and assess impact of evolving information on operational strategies.
• Exhibit the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment.
• Participate in both regional and global projects representing Clinical Operations and Study Optimization to support BeiGene R&D goals.

Computer Skills:

• Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Trialtrove, etc.) and additional feasibility software

Other Qualifications:

• Bachelor’s degree in a scientific, medical or healthcare discipline
• 2+ years of combined experience in Feasibility, Clinical Trial Management, Personnel Management and Operations Management.
• Experience with trial optimization vendors, tools, and methods.
• Proficiency with software models and database structures.
• Expertise in principles driving country/site identification, feasibility, and study startup strategies.
• Validated experience in data analysis, data interpretation to drive inform decision making
• Tried experience in managing, influencing, building and managing relationships and achieving results with senior partners in conflicting priority environment
• Shown experience or willingness to learn how developing study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives
• Clinical trial patient and investigator recruitment experience
• Confirmed experience working with Global teams

Travel:

• Travel might be required as per business need