Clinical Trial Manager

The Clinical Trial Manager will oversee all pre-market and post-market clinical activities, ensuring regulatory compliance and impactful outcomes for KLISBio's orthopedic medical devices. This role involves close collaboration with CROs, clinical sites, KOLs, and internal teams to advance clinical trials and support KLISBio’s product portfolio. Duties And Responsibilities Develop, initiate, oversee, and close clinical trials, ensuring adherence to protocols, GCP, ISO 14155, and regulatory standards. Select, negotiate, and manage CROs, labs, and other vendors; oversee site activities, including site selection, initiation, monitoring, and close-out. Manage essential study documents (protocols, consents, CSRs) and ensure alignment with FDA, EU MDR, and other regulatory bodies. Develop and manage clinical study budgets and timelines to achieve cost-effective and timely study completion. Coordinate with CROs and data management teams to maintain high standards of data accuracy; review data management and statistical analysis plans. Identify and mitigate risks related to study conduct, patient safety, and regulatory compliance, addressing protocol deviations and adverse events. Facilitate communication between Clinical Affairs, Regulatory Affairs, Quality Assurance, R&D, and Marketing teams; act as the clinical liaison with KOLs and surgeons. Design and implement Post Market Surveillance SOPs and plans to ensure compliance with regulatory requirements. Collaborate with Marketing in defining product claims and drafting materials; attend conferences to provide clinical insights. Act as the clinical contact for KOLs and surgeons within the KLISBio network. Collaborate with the R&D team for market needs identification and evaluation. Support R&D, Marketing, and Sales teams by attending industry conferences and fairs, providing clinical insights and expertise. Lead medical writing efforts, including study protocols, reports, and publications, contributing to the visibility and credibility of KLISBio’s innovations. Education And Experience Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field; Ph.D. preferred. 5 years managing medical device clinical trials; overseeing outsourced trials with CROs is a plus. Expertise in GCP, ISO 14155, FDA regulations, and EU MDR. Strong project management skills with a focus on budget, timeline, and resource management. Excellent interpersonal and negotiation skills for working with internal teams and external partners. Knowledge digital clinical trial management systems (CTMS) is a plus. The ideal candidate is a proactive, detail-oriented clinical expert who thrives in a fast-paced startup, adept at balancing clinical rigor with operational efficiency, and skilled in fostering effective collaborations to drive clinical and business success. J-18808-Ljbffr

Location: bresso, IT

Posted Date: 1/15/2025