Clinical Trial Manager

🕒 il y a 15 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🔴 Expert

🧪 Chercheur Clinique

👻 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

• Review project scope and resourcing related to Clinical Monitoring • Plan and implement clinical monitoring aspects of projects • Define and implement project-specific functional standards, goals, expectations, KPIs, KRIs, QTLs, and metrics • Serve as the primary contact for Clinical Monitoring aspects of designated projects • Advocate for the Clinical Monitoring team with clients • Coordinate and oversee daily operations of CRAs and in-house personnel • Ensure assigned CRAs receive therapeutic and project-specific training • Develop CRA tools and training materials • Organize and conduct CRA meetings and calls • Track study information related to Clinical Monitoring deliverables • Oversee clinical monitoring metrics, visit reports, action items, query resolution, and quality metrics • Oversee visit report review and approval, site issue escalation, and resolution • Manage clinical monitoring milestones and address deficiencies • Oversee clinical data quality and timeliness in the eDC • Oversee and maintain core clinical portions of the Trial Master File according to SOPs • Participate in clinical monitoring risk planning, assessment, mitigation, issue escalation, and resolution • Ensure completion of clinical monitoring and site-management closeout activities • Mentor CRAs and provide performance feedback • Serve as CRA trainer/mentor and accompany CRAs on field training, assessment, oversight, or co-monitoring visits • Develop cross-functional relationships with internal and external team members • Undertake specific CPM tasks as agreed with the Line Manager • Understand and oversee CRA timesheets and escalate budget variances • Serve as a resource for investigative sites • Conduct on-site or remote monitoring activities, including pre-study and site initiation visits • Act as primary monitoring contact for sponsors and sites on smaller or single-service projects • Participate in bid defense planning and meetings • Perform other assigned duties

🎯 Exigences

• At least 8 years as a CRA or other pertinent clinical research experience • Prior proficient performance as Lead CRA for at least 1 year • Maintained fully performing or exceeds-level KPIs and metrics for at least 2 years • Demonstrated successful Senior CRA performance • At least 4 of the required 8 years as a CRA monitoring complex studies • Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science; or RN with Associate's Degree; or 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources • Experience conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO • Fluent in English

🏖️ Avantages

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and global volunteering opportunities • Work contributing to life-changing treatments for patients with chronic and critical illnesses