PJoin to apply for the bClinical Trial Manager /b role at KLISBio. /ppThe 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. /ph3Duties And Responsibilities /h3ulliDevelop, initiate, oversee, and close clinical trials, ensuring adherence to protocols, GCP, ISO 14155, and regulatory standards. /liliSelect, negotiate, and manage CROs, labs, and other vendors; oversee site activities, including site selection, initiation, monitoring, and close-out. /liliManage essential study documents (protocols, consents, CSRs) and ensure alignment with FDA, EU MDR, and other regulatory bodies. /liliDevelop and manage clinical study budgets and timelines to achieve cost-effective and timely study completion. /liliCoordinate with CROs and data management teams to maintain high standards of data accuracy; review data management and statistical analysis plans. /liliIdentify and mitigate risks related to study conduct, patient safety, and regulatory compliance, addressing protocol deviations and adverse events. /liliFacilitate communication between Clinical Affairs, Regulatory Affairs, Quality Assurance, RD, and Marketing teams; act as the clinical liaison with KOLs and surgeons. /liliDesign and implement Post Market Surveillance SOPs and plans to ensure compliance with regulatory requirements. /liliCollaborate with Marketing in defining product claims and drafting materials; attend conferences to provide clinical insights. /liliAct as the clinical contact for KOLs and surgeons within the KLISBio network. /liliCollaborate with the RD team for market needs identification and evaluation. /liliSupport RD, Marketing, and Sales teams by attending industry conferences and fairs, providing clinical insights and expertise. /liliLead medical writing efforts, including study protocols, reports, and publications, contributing to the visibility and credibility of KLISBio’s innovations. /li /ulh3Education And Experience /h3ulliBachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field; Ph.D. preferred. /lili5+ years managing medical device clinical trials; overseeing outsourced trials with CROs is a plus. /liliExpertise in GCP, ISO 14155, FDA regulations, and EU MDR. /liliStrong project management skills with a focus on budget, timeline, and resource management. /liliExcellent interpersonal and negotiation skills for working with internal teams and external partners. /liliKnowledge of digital clinical trial management systems (CTMS) is a plus. /li /ulpThe 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. /p #J-18808-Ljbffr