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Job #02549

About our client Our client is a publicly traded biopharmaceutical company headquartered in Washington that is dedicated to the development and commercialization of antibody-based therapeutics for the treatment of cancer. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Trials Manager Seattle, Washington Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Monitor and conduct clinical trial, both directly and working with contracted organizations (e.g. CROs) 2) Ensure that all the tasks are completed on time and in accordance to the ICH/GCP and the company needs 3) Mentor and oversee the junior members of the Clinical Trial Team 4) Manage direct reports 5) Coordinate and manage vendor processes for the monitoring function of the clinical projects, including data management and central laboratories 6) Act as Protocol Lead on one or more projects 7) Act as the primary contact person for the CROs and the Clinical Monitoring Team and ensure that the proper quality and performance of work is met 8) Coordinate day-to-day activities for the monitoring function of clinical studies, including flow of documents and information to and from sites and/or external vendors 9) Facilitate the flow of information between contract CRAs, CROs, the in-house team members and other involved members of the department and CTI 10) Develop quality-control program for each clinical trial and oversee implementation (i.e. co-monitoring, periodic review of adherence to monitoring plan, etc.) 11) Participate in reviewing clinical protocols 12) Check the quality and deliverables of the CRAs 13) Participate in the design of clinical studies in collaboration with senior management, medical monitoring staff, bio-statistician and regulatory affairs members 14) Assist in initiating, monitoring and coordinating day-to-day operations of investigational study sites (as needed) 15) Manage drug accountability systems, including the management of drug accountability for the study 16) Participate in creating and tracking detailed monitoring plans for clinical projects 17) Develop standard reports and templates 18) Participate in evaluating, training and refining departmental SOPs and guidelines 19) Coordinate/prepare clinical documents such as protocols, case report forms and informed consent forms 20) Solve any problem that arises in the clinical study or any related personnel issues 21) Participate in the identification, evaluation and selection of the clinical investigators and investigative sites 22) Collaborate with supply-chain to coordinate drug supply and the final study-level drug accountability 23) Mentor and train the clinical staff in study management and GCP 24) Manage internal (dotted line or functional) and external CRAs along with other external vendors (as necessary) 25) Co-monitor as per the quality plan and ensure that the findings are distributed to the sites (as applicable) 26) Participate in other co-monitoring activities (as and when needed) Requirements 1) Bachelor's degree in a scientific discipline or RN (advanced degree a plus) 2) 10+ years of clinical monitoring experience or equivalent 3) Minimum 5 years of experience in CRA/CRO management or equivalent 4) Experience of oncology and hematology 5) Experience in managing personnel 6) Experience of FDA and ICH requirements 7) International trial management experience 8) Experience in managing a CRO 9) Knowledge of European Clinical Trial Directive 10) Understanding of clinical drug-development process relationships a plus 11) Proven proficiency in development of clinical tools and documents 12) Ability to plan, organize and conduct clinical studies 13) Superb communication and organization skills 14) Excellent clinical monitoring skills 15) Willingness to travel (both domestic and international)