September 03, 2016

Clinical Trial Manager II

Five Prime Therapeutics, Inc. - South San Francisco, CA

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Job Description

div id="contentwrapper" p strong Five Prime Therapeutics, Inc.  /strong (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immune-oncology protein therapeutics for patients with serious unmet medical needs.  Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. /p p We currently have three protein therapeutics in clinical trials: /p ul li style="text-align: justify;" FPA008 – a monoclonal antibody that inhibits the CSF-1 receptor and is being studied in multiple tumor settings and pigmented villonodular synovitis (PVNS) /li li style="text-align: justify;" FPA144 – a monoclonal antibody targeting FGFR2b for selected gastric cancers /li li style="text-align: justify;" FP1039 – a FGF ligand trap for mesothelioma /li /ul p On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies.  We currently have three active research collaborations with Bristol-Myers Squibb, GlaxoSmithKline and UCB Pharma, S.A. /p p Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases.  These values are reflected in our people and our products.  We value our culture of openness, collaboration and productivity.  Discover more about Five Prime at a href="/" /a . /p h2 The Position /h2 p We are seeking a highly motivated individual to join the Five Prime Therapeutics Inc. Clinical Operations group. This individual will play a key role in assisting the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. Overall responsibilities may include the management of clinical operations activities and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve trial objectives and corporate goals. /p p Key accountabilities: /p ul li style="text-align: justify;" Responsible for leading and supporting defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines under direction of the Clinical Program Manager (CPM) or Associate Director/ Director of Clinical Operations /li li style="text-align: justify;" Serve as a member of one or more cross-functional Study Execution Team(s) (SET) and may lead a SET under the direction of a CPM/AD/D /li li style="text-align: justify;" Under the direction of the CPM/AD/D, develop and facilitate RFPs for assigned vendors, review proposals and make award recommendations, participate in selection of CROs and vendors /li li style="text-align: justify;" Responsible for the day-to-day management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement /li li style="text-align: justify;" Participate in developing and finalizing cross-functional SET deliverables such as clinical study protocols, CRFs, consent forms, study reference manuals, study reports, annual reports and other clinical documents /li li style="text-align: justify;" Manage study budget for assigned vendors; review vendor invoices against contract and work completed; identify and transparently communicate variances /li li style="text-align: justify;" Partner closely with CPM/AD/D, Clinical Development and CRO to identify and select clinical trial sites /li li style="text-align: justify;" Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution /li li style="text-align: justify;" May perform oversight and/or co-monitoring of clinical sites as required by the needs of project /li li style="text-align: justify;" Work with SET, external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’ /li li style="text-align: justify;" Coordinate and participate in routine and final database lock listings review /li li style="text-align: justify;" Participate in implementation and oversight of study systems and including CTMS, TMF, EDC, IxRS, and sample management /li li style="text-align: justify;" May draft and implement assigned study management plans, including monitoring, vendor oversight, biosample management, TMF oversight, risk management, quality management and medical monitoring /li li style="text-align: justify;" Create, maintain and conduct ongoing quality review of the TMF to ensure files are properly maintained and up to date, archived and stored /li li style="text-align: justify;" Track key study metrics using tracking tools, providing timely and quality updates to the SET /li li style="text-align: justify;" Identify potential issues and risks, and propose potential resolutions /li li style="text-align: justify;" Develop strong working relationships and maintain effective communication with key internal and external stakeholders /li li style="text-align: justify;" Plan investigator meetings; develop content and present site training materials /li li style="text-align: justify;" Train vendors and team members on study protocol and processes /li li style="text-align: justify;" Participate in department process improvement initiative and system implementation /li li style="text-align: justify;" May review and revise SOPs, working practices and other infrastructure as directed /li /ul