Senior Clinical Project Manager

🕒 il y a 22 jours

🌐 Royaume-Uni, Espagne, +1 autres pays – Distant

🇬🇧 Royaume-Uni – Télétravail 🇪🇸 Espagne – Télétravail 🇮🇱 Israël – Télétravail

⏰ Temps Plein

🟠 Senior

🏥 Responsable des Opérations Cliniques

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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CTI Clinical Trial and Consulting Services

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1999

💼 Conseil

🏥 Santé

🧬 Biotechnologie

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services est une organisation de recherche sous contrat (CRO) à service complet qui offre l'exécution d'essais cliniques, une stratégie réglementaire, des services de laboratoire et bio-analytiques, la génération de preuves du monde réel et la gestion de centres de recherche pour les promoteurs biotechnologiques et pharmaceutiques. Avec une expertise couvrant les études de phase I à IV et des domaines thérapeutiques complexes (y compris les maladies rares, la thérapie cellulaire et génique, l'oncologie, la neurologie et la transplantation), CTI soutient la conception d'études, la gestion de sites, le recrutement de patients, la surveillance, la sécurité/pharmacovigilance, la biométrie et l'assurance qualité. Basée à Covington, KY, l'entreprise met l'accent sur des approches intégrées et centrées sur le patient et sur l'orientation réglementaire mondiale pour accélérer le développement et apporter des thérapies aux 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

🎯 Exigences

• 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

🏖️ Avantages

• 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