Project Manager W2 ONLY 7323771

South San Francisco, CA

Post Date: 06/29/2017 Job ID: 3030 Industry: Professional Positions

Duties:

Accountable to the Protocol Exectution Teams (PET) and partners with the PET to efficiently deliver effective clinical systems and solutions
  • Manages the end-to-end specifications for the build of all clinical trial systems needed for a given study, including requirements reviewing, testing, deployment, maintenance, and supporting infrastructure
  • Continually assesses the needs of the PET, consults the PET, and proactively finds system and solution recommendations to address their needs
  • Serves as first line of contact for all support requests for each clinical study
  • Ensures prompt resolution of critical system issues and provides timely and accurate responses to users, per the standard operating procedures
  • Identifies business needs / issues and provides technical solutionsto address them
  • Gathers, receives and interprets requirements from end users and documents business requirements
  • Monitors key performance indicators and conducts analysis to identify root causes for defects and recommend process improvements
  • Identifies process inefficiencies and compliance gaps and participate in process improvement initiatives
  • Acts as the subject matter expert for Sys Ops supported systems
  • Develops strong relationships and maintains effective communication within the ClinOps, as well as other functional departments within the company
  • Reports to the gRED Clinical Operations Sys Ops Manager

 

Skills:

Knowledgeable with the processes and principles of program and project management and business analysis
  • Up-to-date knowledge of clinical operations processes and information systems
  • Experience managing third party vendors in delivering quality service as expected
  • Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies
  • Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
  • Previous experience in clinical trial planning and execution
  • Ability to successfully lead a team or change initiative through implementation with little or no oversight
  • Knowledgeable with Clinical Operations and Information Systems such as EDC, IxRS, Crystal, FELIx, and Clinical Supply Systems
  • Demonstrated leadership and project management skills
  • Ability to drive results to successful completion
  • Analytical problem solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root-causes
  • Comfortable working in a fast-paced, dynamic environment
  • Highly proficient in Microsoft Excel, Microsoft Project and Microsoft Word
  • Highly effective verbal & written communication skills
  • Highly effective team player and interpersonal skills (globally, internal and externally)
  • Strong customer focus

 

Education:
  • Bachelor’ s degree (MBA or advanced degree preferred)
  • 5+ years’ experience in Biotech/Pharmaceutical industry

Calley Molina


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