Clinical Program Director

3 days ago


California, United States EPM Scientific Full time
Job Summary

EPM Scientific is seeking a highly motivated and experienced Clinical Program Lead to join our team. As a Clinical Program Lead, you will be responsible for managing a Phase III global study and leading the design, monitoring, data interpretation, and reporting activities related to the conduct of clinical studies.

Key Responsibilities
  • Study Management: Manage a Phase III global study, ensuring timely and successful completion.
  • Design and Monitoring: Lead the design, monitoring, data interpretation, and reporting activities related to the conduct of clinical studies, in accordance with applicable regulations, ICH/GCP regulations, and Standard Operating Procedures (SOPs).
  • Process Implementation: Implement processes and initiatives to support the clinical program and study delivery, driving overall portfolio delivery.
  • Team Support: Support the Director, Global Clinical Affairs, and oversee the execution of scientific components of the program, including scientific literature review, protocol development, and Quality by Design principles.
  • Clinical Sites: Oversee clinical sites, including support for clinical study leads and project associates in management and oversight.
  • Data Management: Ensure data quality, patient safety, and data management/cleaning activities.
Requirements
  • Experience: 3+ years of sponsor experience, with 2+ years of experience managing studies or trials in the EU.
  • Education: Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or a related discipline.
  • Skills: Working knowledge of ICH GCP guidelines, on-site monitoring experience, and excellent communication and leadership skills.
What We Offer
  • Competitive Salary: A competitive salary with benefits.
  • Commercial Exposure: High degree of commercial exposure early in your career.
  • Meaningful Work: Being part of a team whose work directly aims to improve the quality of people's lives.
  • Work-Life Balance: Great work-life balance.


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