Clinical Trial Manager (CTM), Europe

Zogenix ,
Maidenhead, Berkshire
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Company Overview Headquartered in Emeryville, CA, Zogenix is a biopharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. We are currently looking to hire an Clinical Trial Manager (CTM), Europe. This is an exciting opportunity to join the Clinical Development function at Zogenix and to support the European launch of the company's first commercial product along with providing support for other business objectives. The role will be based in our EU office in Maidenhead. Job Summary The Clinical Trial Manager is responsible for the day to day oversight of global clinical trials and managing the Study Team, vendors, clinical monitors, and clinical trial sites. The CTM will focus mostly on managing Phase III multinational, multicenter clinical trials, with some possible management of early phase development studies (phase I/II studies). This position will work closely with a cross-functional team based in the US and EU to ensure that clinical trials are conducted in compliance with Standard Operating Procedures (SOPs), ICH GCP, regulatory guidelines and company goals. The CTM is responsible for delivering a quality study on time and within budget. Responsibilities and Duties * Participates in and facilitates the Clinical Research Organisation (CRO)/vendor selection processes for outsourced activities including Request for Proposals (RFPs). * Provides oversight to the CRO(s) managing clinical studies within the region(s). * Oversees site start up, subject recruitment, enrollment, study management, Investigational Product management , monitoring, site management, Trial Master File (TMF) set-up and maintenance, data cleaning and study closeout. * Participates in CRF design, project plan and clinical report writing. * Proactively identifies potential study issues/risks and recommends/implements solutions. * Develops, reviews and approves regulatory and other required study documents * Manages ongoing communication of operational issues and provides accurate progress reports on assigned activities to the Study Team * Manages site and/or vendor budget and timelines. * Contributes to projects that support wider organizational goals. * Assists in SOP writing and review * Other duties as assigned Qualifications and Skills * Bachelor's degree in a health sciences field * Minimum 5 years' experience in a similar role in the life science industry * Sound understanding of GCP and other applicable guidelines/regulations * Experience in managing CROs, specialty labs and vendors in global, multinational Phase 3 programmes * Experience in management of paediatric studies desirable * Proficient in software applications such as Word, Excel and PowerPoint * Excellent written and verbal communication skills * Ability to multitask under pressure * Strong organizational skills with attention to detail * Good problem-solving and analytical skills * Ability to effectively collaborate in a dynamic environment * Fluency in another European language desirable * Able to work outside normal UK business hours, as required * Able and willing to travel up-to 30%. 50% travel may be required at times * Other duties as assigned Apply for this Job

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