Senior Clinical Trials Manager

Emploi pas sur LinkedIn

🕒 il y a 1 mois

🌵 Arizona, District of Columbia, +3 états de plus – Distant

🌵 Arizona – Remote 🏛️ District of Columbia – Remote 🏖️ New Jersey – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote

💵 $127 680 - $213 465 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

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Agilent Technologies

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1999

🔬 Science

🧬 Biotechnologie

💊 Pharmaceutique

💰 €500 000 000 Post-IPO Debt en 2019-09

Science • Biotechnology • Pharmaceuticals

Agilent Technologies est un leader mondial dans le domaine des instruments analytiques et de laboratoire. L'entreprise propose une gamme diversifiée de produits et de solutions, notamment en chromatographie en phase gazeuse et liquide, spectrométrie de masse, fournitures de laboratoire, ainsi que logiciels et informatique. Agilent dessert divers secteurs, tels que la biopharmacie, le contrôle des aliments et boissons, le diagnostic clinique et les tests environnementaux. De plus, Agilent offre des services complets de gestion de laboratoire, de maintenance et de réparation d'instruments. L'entreprise met un fort accent sur l'avancement de la science grâce à des solutions durables et soutient la recherche en génomique, pathologie et cancer avec des technologies avancées.

Description

• Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. • Support and oversee study-related work of Clinical Research Associates (CRAs) to ensure proper site training and management • Manage study deliverables and track study metrics including identifying potential risks to study timelines and/or conduct • Review, suggest edits and approve monitoring trip reports for studies • Participate in data management activities, such as CRF development, training, and facilitating query resolution • Lead or contribute to organizational and departmental process development, improvement, and implementation • Provide guidance and mentorship to junior team members.

🎯 Exigences

• Bachelor's degree or higher, or equivalent credentials • Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements • Strong interpersonal skills (verbal and written), organizational, and prioritization skills • Ability to work independently and effectively in a fast-paced environment • Strong work ethic and ability to deliver tasks on time • Proficient with office automation tools, especially Microsoft PowerPoint, Excel and Word. • For Sr CTM: 5+ years of clinical study management experience in sponsor, CRO and/or companion diagnostics, device manufacturer, IVD, or similar industry(ies) demonstrating effective and successful study management from study inception through close-out. • Experience in line management of CRAs and CTMs preferred.

🏖️ Avantages

• Bonus • Stock options • Health insurance • Paid time off • Remote work options