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Scientific. Clinical. Engineering

Global Study Director

San Mateo Metro Area, CA

Employment Type: Full-Time Job Type: Clinical Job Number: JN -062022-30532 Region: San Mateo Metro Area

Job Description

Our biopharmaceutical client is recruiting for a Global Study Director to join their growing team.

Summary:
  • Lead a study management team to ensure the clinical program progresses as plan and drive achievement of timelines, budget and quality standards
  • Ensure all external service providers engaged are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning and control activities
  • Develop and maintain relevant study plans including required input into study level quality and risk management planning with risk response strategies and clear issue resolution pathways
  • Oversee study level performance against agreed upon timelines by using company tracking systems and project timelines
  • Responsible for study budget re-forecasting and accountable for budget management through the study lifecycle
Requirements:
  • Bachelor s degree in life sciences
  • 7 plus years clinical trial experience and over 3 years of global study leadership experience
  • Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; start up, maintenance and close out
  • Strong abilities in establishing and maintaining effective working relationships with strong conflict management skills
  • Ability to lead multiple challenging priorities and demonstrated experience in external provider oversight and management
**Local Candidates Only**
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