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Scientific. Clinical. Engineering
R&D Partners
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Global Study Director
San Mateo Metro Area, CA
2022-06-14
2022-07-26
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:
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
- 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