|Clinical Trial Manager
Theraclone Sciences is a Seattle-based biotechnology company focused on the development of novel, therapeutic, human-antibodies for the treatment of infectious disease and cancer, and as a basis for vaccine development. Theraclone is a privately held company with venture investment from ARCH Venture Partners, Canaan Partners, Healthcare Ventures, MPM Capital, Amgen Ventures and Alexandria Real Estate Equities. For additional information, please visit www.theraclone-sciences.com
Theraclone is seeking a motivated and experienced Clinical Trial Manager to plan, initiate and execute assigned clinical studies with operational excellence. The individual in this role will be accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality. This position will also be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies.
The scope of this position is Phase 1 through 3 clinical studies. Primary duties and responsibilities include, but are not limited to: Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities. Coordinate clinical study timelines to meet critical milestones; escalate issues that may jeopardize timelines and deliverables. Conduct study monitoring visits and co-monitoring visits as needed. Provide regular updates of study progression to Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues. Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance. Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team. Lead feasibility assessment and selection of countries and sites for study conduct. Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans. Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents. Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational training for internal and external study team members.
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