Senior Clinical Project Manager

🔥 0 minutes ago

🌐 United Kingdom, Spain, +1 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇮🇱 Israel – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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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 full execution of assigned clinical trials, often functioning as a global trial lead • Set goals and timelines and provide oversight and leadership to clinical trial teams • Coordinate operational aspects of functional areas to ensure compliance with ICH, GCP, regulatory guidelines, and trial procedures • Manage full-scope clinical trial projects from start-up through analysis, including global trials • Manage multiple projects and functionally assigned team members • Implement project activities according to contracted scope • Evaluate and manage project budgets, milestones, scope, and profit margins • Assess contractual scope and facilitate change-of-scope orders when appropriate • Develop or oversee trial plans, timelines, schedules, resources, budgets, and deliverables • Serve as the client contact at the project operational level • Oversee contracted vendors and third-party vendor financial spend • Monitor trial KPIs and implement mitigation strategies • Oversee project tracking and timely data entry for accurate reporting • Monitor resource needs and communicate resource or performance issues • Ensure appropriate training for assigned clinical trial teams • Oversee CRA tasks, site management, clinical trial data monitoring, 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 and presentations • Ensure completeness, accuracy, and maintenance of the TMF and conduct regular audits • 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 regionally required • Assist with payment projections, payment records, site budget negotiations, and regional site payment activities

🎯 Requirements

• Bachelor’s degree in an allied health field such as nursing, pharmacy, or health science, or equivalent combination of education and relevant work experience • At least 6 years of clinical research experience in CRO, CRA, research management, site research management, or central clinical research laboratory management; alternatively, transferable project management experience in a clinical or related industry • Clinical trial management experience preferred • Fluent in English • Ability to plan and manage full-scope clinical trials from start-up through analysis • Ability to manage multiple projects simultaneously • Knowledge of ICH guidelines, Good Clinical Practices, applicable regulatory guidelines, and trial procedures • Experience with clinical trial budgets, milestones, scopes, profit margins, and change orders • Experience overseeing clinical trial teams, CRAs, sites, vendors, and third-party financial spend • Ability to manage and audit the Trial Master File • Ability to lead client, team, and Investigator meetings • Ability to prepare or oversee trial plans, timelines, schedules, resources, budgets, deliverables, and status reports • Ability to support business development activities and process improvement initiatives

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and world impact opportunities • Award-winning culture prioritizing people • Work-life balance support • Opportunity to contribute to life-changing treatments for patients