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 global experience preferred
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com
Why CTI?
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
- Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you’re selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from a @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
- We will never communicate with you via Microsoft Teams or text message
- We will never ask for your bank account information at any point during the recruitment process