Sr. clinical trial manager (contract) – rare disease – oakland
Employment Type: Full-Time
Summary MEET is working with a new Biotech in the East Bay that specializes in rare diseases looking for a new Contract Senior Clinical Trial Manager. Our partner is a biopharmaceutical company focuses on developing disease-modifying therapies for rare genetic diseases to help improve the lives of their patients. Responsibilities The Senior Clinical Trial Manager will have the opportunity to come in and lead a registrational trial in an ultra-rare disease. They are responsible for the day to day oversight of global clinical trials and will manage the Study Management Team, vendors, clinical monitors, and clinical trial sites. This position will work closely with a cross-functional team based in the US and EU to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP Country-specific regulatory guidelines, company goals, and budgets. The Sr CTM will be responsible for managing various project goals and delivering a quality study on time and within budget. • Participates in and facilitates the CRO/vendor selection process for outsourced activities including the request for proposal (RFP) process. • Oversees site start-up, subject recruitment, enrollment, study management, monitoring, site management, clinical trial master files, and data clean up. Participates in CRF design, project plans, and clinical report writing. • Manages study-related activities including timelines, study visits, site selection, site initiation, study drug management, and closeout activities. • Manages ongoing communication of operational issues and provides accurate progress reports on assigned activities to the Study Team. Requirements • Bachelors degree or equivalent required (scientific or healthcare discipline preferred) • 7+ years of study management experience in clinical and drug development • Experience in managing CROs, specialty labs and outside vendors in global •MSOffice skills required (Outlook, Word, Excel, PowerPoint) • Travel up to 50% of the time Contact Full job description and company details are available upon application. This position is being dealt with by Alex Truong at Meet, call on 415.992.5856 or email directly at firstname.lastname@example.org to discuss further and in confidence. You can find out more about Meet at www.peoplewithchemistry.com
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