Senior Manager, Feasibility

Job Summary: The Senior Feasibility Manager develops and oversees collaborative relationships with internal departments and external clients to conduct and ensure delivery of high-quality strategic and trial related feasibility including country/site/investigator identifications and assessments. This includes management of departmental profitability compliance and efficiency metrics/ KPIs and coordinates delivery of feasibility projects and strategic initiatives according to contractual and internal obligations.  Provides line management for Feasibility Specialists.

 

What You'll Do

• Oversees set-up, survey programming, securing of resources and overall conduct for allocated feasibility studies according to timeline, quality standards, and client expectations for all phase study type awards, and rescue and feasibility only opportunities; includes leading mid-level partnerships and client alliances.
• Collaborates on development of initial site and country list (initial site prioritization).
• Ensures accuracy and quality of survey driven data, including review and quality control (QC) of departmental deliverables at all stages of feasibility process.
• Oversees and analyzes project statuses to ensure successful completion of milestones, timelines, and deliverables.
• Serves as primary point-of-contact (PoC) for department and collaborates cross-functionally.
• Works with team to identify potential risks and out-of-scope (OOS) activity by managing the monthly financial deliverables (unit tracking/percent completes, resourcing projections); discusses contingency plans with strategist and/or Clinical Project Manager (CPM) or Dept. VP; identifies risk trends across projects.
• Contributes to development, testing, and maintenance of feasibility system.
• Actively participate in developing relevant study metrics to measure the impact of feasibility strategy, including country and site recommendations and enrollment projections.
• Provides input for new business development (NBD) proposals to help build project assumptions, budgets, timelines and strategic feasibility direction.
• Leads and/or contributes to internal planning meetings for bid defense and capabilities presentations, training calls, client Kickoff Meetings (KOMs), and interim client teleconferences.
• Provides appropriate education and training to CTI staff to maintain up-to-date understanding of International Council for Harmonisation (ICH) / Good Clinical Practices (GCPs) and other applicable regulations.
• Develops or updates relevant Global Standard Operating Procedures (GSOPs) as needs are identified and monitors for process updates and improvements to current GSOPs.
• Trains and mentors new / existing feasibility staff and other CTI functional staff members who are doing feasibility work.
• Provides guidance and mentorship to direct reports while overseeing and managing their work product.
• Provides Line Management for a remote global team of Feasibility Specialists.
• Serves as an escalation point for site follow up when escalation is needed by the feasibility specialist.
• Performs data analysis using multiple platforms including Tableau and other AI platforms to visualize and summarize survey data.
• Ability to Lead standalone Feasibility services as needed and described below:
• Research, compile, and analyze information on therapeutic area(s), collects information regarding incidence, prevalence, standard-of-care (SoC), factors determining and influencing indication frequency and distribution, treatment trends, competing trials, etc
• Databases and literature search for sites identification and identification / selection of sample sites
• Designs site surveys / questionnaires to obtain key information (e.g., investigator feedback on projected enrollment, feasibility of the study, and site capabilities)
• Surveys data collection platform stetting-up (eg Monkey survey)
• Oversees site information collection process and assesses compiled information for trends and site capabilities.
• Follows up with internal team and/ or sites team regarding surveys completions
• Compiling feasibilities status for internal or external client
• Compiles information into CTI feasibility database
• Logistics organization and feasibility attendance calls with sites
• Supports in preparing presentations and/or written reports, as required, and delivers to internal / external stakeholders in determined forum (e.g., client or team meeting)

 

What You'll Bring

• Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• At least 5+ years in the Clinical Research, Pharma or CRO with glob