Clinical Trial Manager I - South San Francisco, CA | Biospace
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Clinical Trial Manager I

Five Prime Therapeutics, Inc.

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Location:
South San Francisco, CA
Posted Date:
7/21/2017
Position Type:
Full time
Job Code:
324
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development.   

  •      Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)    
  •      FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer    
  •      FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma    

   Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads.  Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas.  FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.  

   The Position  

   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 include supporting the management of clinical operations activities and coordinating cross functional efforts in the implementation and conduct of a clinical trial(s) under the direction of the Study Execution Team Leader (SETL) in order to achieve trial objectives and corporate goals.  

   Essential functions:  

  •      Support 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    
  •      Serve as a member of one or more cross-functional Study Execution Team(s) (SET)    
  •      Contribute to the development of RFPs for assigned vendors, review proposals and make award recommendations, participate in selection of CROs and vendors    
  •      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    
  •      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    
  •      Manage study budget for assigned vendors; review invoices for assigned vendors, identify and communicate variances for assigned vendors    
  •      Partner closely with Senior CTM/CPM, Clinical Development and CRO to identify and select clinical trial sites    
  •      Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution    
  •      Perform oversight and/or co-monitoring visits of clinical sites as required by the needs of project    
  •      Review and approve monitoring reports and escalate issues and risks to Senior CTM/CPM    
  •      Assist with ensuring that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled    
  •      Coordinate and participate in routine and final database lock data listings review    
  •      Participate in implementation and oversight of study systems e.g, CTMS, TMF, EDC,or IxRS    
  •      Contribute to creation and implementation of assigned study management plans, (e.g. monitoring, vendor oversight, TMF oversight)    
  •      Ensure that supportive study supplies and documents are available (e.g., contracts, IXRS, lab kits, non-clinical supply materials)    
  •      Create, maintain and conduct ongoing quality review of the TMF to ensure files are properly maintained and up to date, archived and stored    
  •      Reconcile site payments against patient visits to ensure accurate payments    
  •      Track key study activities using tracking tools    
  •      Identify issues and risks, and propose potential resolutions    
  •      Assist with planning investigator meetings and developing content and/or site training materials    
  •      Assist with training vendors and team members on study protocol and processes    
  •      Attend meetings, takes and distributes meeting minutes    
  •      Participate in department process improvement initiative and system implementation    

Requirements

  •      BS/BA in Life Science or related discipline    
  •      3+ years industry experience in clinical drug development      
  •      Effective team player and ability to influence and collaborate with cross functional clinical study teams    
  •      Effective written and interpersonal communication skills    
  •      Ability to manage delegated aspects of assigned clinical trials    
  •      Ability to manage assigned clinical study vendors    
  •      Strong planning and organizational skills    
  •      Working knowledge of FDA & ICH/GCP regulations and guidelines    
  •      Ability to travel internationally up to 25%    

   Please upload your cover letter and resume.  

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