About this role
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. Clinical Project Managers plan, implement, evaluate, and complete full execution of assigned clinical trials, often functioning as global trial leads. The role involves managing projects from drug concept through commercialization in collaboration with pharmaceutical and biotech firms.
Day-to-day responsibilities include providing oversight and coordination of operational aspects to ensure compliance with ICH guidelines, GCP, and applicable regulatory requirements. Managers set goals, foster team motivation, and handle resource needs while monitoring project tracking with computer-assisted programs. They prepare trial plans, timelines, schedules, resources, and budgets, addressing challenges with assigned trial directors.
In this team-oriented environment, professionals serve as client contacts at the operational level and oversee contracted vendors to meet timelines. They provide guidance on trial deliverables, ensure team training for protocol execution, and oversee CRA tasks including site management and data monitoring. Site visits occur as needed to support staff.
Opportunities involve leading client and team meetings for effective decision-making, managing budgets against milestones, and facilitating scope changes. Managers evaluate project performance, escalate issues per communication plans, and maintain accurate reporting to clients and executive management. This role supports global trials with high-quality execution.
Requirements
- Knowledge of ICH guidelines, Good Clinical Practices (GCP), and applicable regulatory guidelines
- Experience managing global clinical trials from start-up through analysis
- Ability to oversee clinical research associates (CRAs) and site monitoring
- Proficiency in clinical trial project tracking using computer-assisted programs
- Skills in vendor management and ensuring compliance with trial procedures
- Expertise in developing trial plans, timelines, resources, and budgets
- Capability to manage multiple clinical trial projects simultaneously
Responsibilities
- Plan, implement, evaluate, and complete full execution of assigned clinical trials, often as global trial lead
- Provide oversight and coordination of operational aspects to ensure compliance with ICH guidelines, GCP, and regulatory guidelines
- Manage full scope clinical trial projects from start-up through analysis phase, overseeing functional team members
- Prepare or oversee development of trial plans, timelines, schedules, resources, and budgets
- Serve as client contact at project operational level and lead client/team meetings
- Provide oversight to contracted vendors and ensure timely project tracking
- Oversee CRA tasks, site management, and monitoring of clinical trial data
- Evaluate and manage project budget against milestones and facilitate scope changes
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