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gRED Clinical Systems Leader
Ref No.: 17-00160
Location: South San Francisco, California
Position Type:Contract
Start Date / End Date: 01/12/2017 to 12/12/2017
Job Title: gRED Clinical Systems Leader
Job Duration: 12 Months
Job Location: South San Francisco, CA


Job Purpose
The Clinical Systems Leader (CSL) ensures that all clinical systems are properly setup and operational for Client Early Clinical Development (Client ECD) Clinical Operations Protocol Execution Teams (PETs), and serve as the primary point of contact for all clinical systems. The CSL has a high degree of expertise in project management, System Development Lifecycle (SDLC), vendor management and direct experience with the tools gthey are servicing.

Primary Responsibilities & Accountabilities
  • Accountable to the Protocol Execution 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 solutions to 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
Experience, Skills, Knowledge
  • 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/Qualifications
• Bachelor's degree (MBA or advanced degree preferred)
• 5+ years' experience in Biotech/Pharmaceutical industry