Clinical Trial Manager, Consultant

🕒 il y a 1 jour

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

⏳ Contrat

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 12%

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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NeuroBionics

Site WebLinkedInTous les Emplois

1 - 10 employés

🏥 Santé

💼 Conseil

⚕️ Assurance santé

💰 €6 000 000 Series A en 2004-12

Healthcare • Consulting • Healthcare Insurance

NeuroBionics est une entreprise pionnière dans le domaine de la bioélectronique, spécialisée dans le développement d’interfaces neuronales innovantes. Sa technologie repose sur des fibres bioélectroniques flexibles, plus fines qu’un cheveu, qui s’intègrent à l’organisme humain pour moduler les environnements biologiques au moyen de signaux électriques, chimiques et mécaniques. NeuroBionics transforme l’administration des traitements de stimulation cérébrale profonde (DBS) en les rendant moins invasifs grâce à des méthodes d’administration endovasculaire. Cette avancée élargit considérablement l’accès des patients à des thérapies susceptibles de changer leur vie et favorise des recherches de pointe en neurosciences.

Description

• Lead operational execution and oversight of the OUS first-in-human implantable neurostimulation study from site activation through study conduct • Monitor and report adverse events and serious adverse events against protocol-defined timelines • Ensure documentation, escalation, and regulatory reporting, including sponsor and IRB/ethics committee notifications as required • Identify, document, assess, and follow up on protocol deviations • Implement corrective and preventive actions with sites and the broader team • Provide day-to-day operational oversight to ensure conduct per protocol, GCP, and applicable OUS regulatory requirements • Oversee the informed consent process in coordination with the local site monitor • Prepare and lead Site Initiation Visits to activate sites and prepare them for enrollment • Provide device and procedure training during site startup • Develop training materials and deliver sessions for site staff, investigators, and internal team members • Develop CRFs and collect, track, and maintain essential documents • Set up and maintain the eTMF as the system of record • Track CRF completeness and drive query resolution with site staff • Coordinate with regulatory, engineering, and quality functions • Communicate study status, risks, and safety findings to internal stakeholders and leadership

🎯 Exigences

• Progressed from a clinical research coordinator (CRC) role into clinical trial management (CTM) or equivalent • Hands-on experience running clinical studies, not only managing from a distance • Medical device trial experience required • Implantable device experience strongly preferred • Direct experience with AE/SAE monitoring, reporting, and protocol deviation management • Experience conducting Site Initiation Visits (SIVs) and site training • Strong working knowledge of GCP and applicable device regulatory frameworks • Familiarity with ISO 14155 is a plus • Comfortable working part-time/fractionally within a small, resource-constrained team • Able to operate independently with minimal clinical operations infrastructure • International/OUS clinical trial experience • Familiarity with non-US ethics committees/IRBs and site relationships • Experience in Europe and/or Canada is valuable • Experience with neurostimulation, implantable, or other active implantable medical devices is preferred • Prior first-in-human (FIH) study experience is preferred • Existing relationships with OUS sites, IRBs, or ethics committees relevant to the program are preferred

🏖️ Avantages

• Part-time consulting/contract engagement • Approximately 10–15 hours/week during steady-state periods, increasing to 25–35 hours/week during site travel and active enrollment weeks • Monthly travel to Europe beginning late October for patient enrollment and site oversight