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About the Role

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the development lifecycle, 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.

Responsibilities

Plan, implement, evaluate, and complete full execution of assigned clinical trials, often functioning as a global trial lead.
Set goals, provide oversight, and foster motivation within the team to accomplish goals within defined timelines and with high quality.
Provide oversight and coordination of operational aspects of functional areas on assigned projects to ensure compliance with ICH guidelines, GCP, applicable regulatory guidelines, and trial procedures.
Manage full-scope clinical trial projects, including global trials from start-up through analysis phase.
Provide oversight of functionally assigned team members on clinical trials projects.
Effectively manage multiple projects simultaneously.
Coordinate clinical trial projects, including organization, implementation, and management of scoped activities.
Prepare or oversee the development of trial plans, timelines, schedules, resources, and budgets.
Work with the team and assigned Trial Director to provide effective solutions to challenges.
Provide oversight and guidance in the development of trial-required deliverables.
Serve as client contact at the project operational level.
Oversee contracted vendors, review specifications, and maintain regular interactions to ensure timelines and expectations are met.
Oversee project tracking using computer-assisted programs and ensure timely entry of project information for accurate reporting.
Monitor ongoing resource needs and keep functional department heads apprised of needs or performance issues.
Ensure assigned clinical trial team receives appropriate training for effective protocol implementation, conduct, and execution.
Oversee Clinical Research Associate (CRA) tasks, including site management and clinical trial data monitoring.
Review and approve site trip reports and escalate site issues as needed.
Attend site visits on an as-needed basis to support CTI and/or site staff.
Implement project activities according to the scope of contracted work.
Evaluate and manage project budget against milestones and scope, collaborating with the Trial Director for corrective measures.
Assess scope of work against client contractual agreement and inform the Trial Director of concerns.
Facilitate change of scope orders when appropriate.
Lead client and team meetings for effective information sharing, discussion, and decision-making.
Ensure accurate and complete documentation of meeting discussions, decisions, and outcomes.
Prepare or oversee/approve weekly and/or monthly project status reports.
Participate and provide oversight in the planning of Investigator meetings, including developing/approving agendas and conducting presentations.
Oversee the management and maintenance of the TMF, ensuring timely document submission and regular audits.
Participate in business development activities, including RFP development, bid defense presentations, and client meetings.
Suggest and participate in process improvement activities and initiatives.

Requirements

Fully eligible to live and work in the country of application; CTI does not offer sponsorship.
Bachelor’s degree in allied health fields (e.g., nursing, pharmacy, health science) or equivalent combination of education and relevant work experience.
At least 6 years of clinical research experience (CRO CRA, Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry.
At least 5 years of experience with therapeutic focus on rare disease, oncology, cell/gene therapy preferred.
Previous technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company, or CRO preferred.
Previous CRA experience preferred.
Experience or education indicating knowledge of medical and pharmaceutical terminology preferred.
Previous experience in a Clinical Project Manager or Clinical Trial Manager level position preferred.

Skills

Clinical trial management
Project management
Team leadership
Budget management
Vendor management
Client communication
Regulatory compliance (ICH, GCP)
Clinical trial planning
Clinical trial execution
Clinical trial monitoring
Data management
Risk assessment
Process improvement

Location

Greater Cincinnati, OH region

Work Type

Hybrid work from home opportunities

Experience Level

At least 6 years clinical research experience
At least 5 years of experience with therapeutic focus on rare disease, oncology, cell/gene therapy preferred
Previous technical and managerial experience preferred
Previous CRA experience preferred
Previous experience in a Clinical Project Manager or Clinical Trial Manager level position preferred

Education Level

Bachelor’s degree in allied health fields such as nursing, pharmacy or health science, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience
Graduate degree preferred

Benefits

Support career progression through a structured mentoring program
Leadership courses for growth
Dedicated training department for ongoing education and training
Award-winning unparalleled culture
Work-life balance support
Importance of time with family
CTI Cares program

About the Company

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.
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.