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CTI Clinical Trial and Consulting Services · 2 days ago

Associate Director, Feasibility

Covington, KY

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization focused on advancing treatments for chronically and critically ill patient populations. The Associate Director, Feasibility role involves managing feasibility specialists and ensuring high-quality feasibility studies, while overseeing project statuses and collaborating with internal and external stakeholders.

BiotechnologyConsultingPharmaceutical

Growth Opportunities

H1B Sponsor Likely

Responsibilities

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)

Qualification

Clinical ResearchFeasibility StudiesData AnalysisProject ManagementTeam LeadershipTrainingRegulatory KnowledgeSurvey DesignClient ManagementGlobal ExperienceStandard Operating ProceduresCommunication SkillsMentoringCollaborationProblem SolvingPresentation Skills

Required

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

Benefits

Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.

Tuition reimbursement

Generous health benefits

Vacation packages

Hybrid work from home opportunities

Paid parental leave

CTI Cares program

Company

CTI Clinical Trial and Consulting Services

CTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services.

Founded in 1999

Covington, Kentucky, USA

1001-5000 employees

http://ctifacts.com

H1B Sponsorship

CTI Clinical Trial and Consulting Services has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2020 (1)