Clinical Project Manager III – Senior CPM

🔥 0 minutes ago

🌐 United Kingdom, Spain, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇵🇹 Portugal – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Plan, implement, evaluate, and complete assigned clinical trials, often functioning as global trial lead • Set goals and timelines and provide oversight and leadership to clinical trial teams • Coordinate operational aspects of functional areas to ensure ICH, GCP, regulatory, and protocol compliance • Manage full-scope clinical trial projects from start-up through analysis, including global trials • Coordinate project activities and implement contracted work scope • Evaluate and manage project budgets against milestones and scope and take corrective action as needed • Assess project profit margins and develop mitigation strategies • Assess scope against client contracts and facilitate change orders • Develop or oversee trial plans, timelines, schedules, resources, budgets, and deliverables • Serve as operational-level client contact • Oversee contracted vendors, specifications, timelines, expectations, and financial spend • Monitor trial KPIs and mitigate activities outside expected ranges • Oversee project tracking and timely information entry for accurate client and executive reporting • Monitor resource needs and communicate issues to functional department heads • Ensure clinical trial team training for protocol implementation and execution • Oversee CRA tasks, site management, monitoring of clinical trial data, site trip reports, and escalation of site issues • Attend site visits as needed • Lead client and team meetings and document discussions, decisions, and outcomes • Prepare or oversee project status reports • Plan and oversee investigator meetings, agendas, materials, and presentations • Maintain and audit the Trial Master File (TMF) for assigned studies • Participate in business development activities, including RFP development, bid defense presentations, and client meetings • Lead or participate in process improvement initiatives • Mentor other CPM staff • Review site and vendor invoices and approve subject milestone payments as required by region • Assist with payment projections and payment record maintenance • Support or conduct regional site budget negotiations • In the EU, coordinate with the EU Clinical Trial Budget Management Team, regional CRAs, and Study Start-up Specialists for site budgets, payments, invoices, and country-specific communications

🎯 Requirements

• 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 • At least 6 years of clinical research experience, including CRO CRA, Research Manager, Site Research Manager, or Central Clinical Research Laboratory Manager experience, or transferable project management skills and experience in a clinical setting or related industry • Fluent in English • Ability to plan, implement, evaluate, and complete full execution of assigned clinical trials • Ability to manage global clinical trial projects from start-up through analysis • Knowledge of ICH guidelines, GCP, applicable regulatory guidelines, and trial procedures • Ability to manage multiple projects simultaneously • Ability to manage project budgets, milestones, scope, profit margins, and vendor financial spend • Ability to oversee clinical trial teams, CRAs, sites, vendors, and TMF completeness • Ability to use computer-assisted project tracking programs • Ability to support or conduct site budget negotiation and manage site payments as regionally required

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares opportunities to give back to the community and world • Work-life balance support • Award-winning culture prioritizing people