Clinical Program Manager - Remote

Overview

The Clinical Program Manager at Cepheid is responsible for managing the overall operation of pre-clinical and clinical trials, ensuring effective communication across various functions and overseeing budget and resource management.

In Short

• Manage pre-clinical and clinical trials operations.
• Oversee project planning and budget management.
• Lead and mentor Clinical Operations staff.
• Develop study-related documents and clinical protocols.
• Communicate effectively with cross-functional teams.
• Ensure adherence to timelines and budget.
• Handle regulatory requirements related to clinical research.
• Travel up to 20% as needed.
• Experience in clinical research within medical devices or pharmaceuticals.
• Flexible remote work arrangement available.

Requirements

• Bachelor’s or Master’s degree in a scientific discipline.
• 8+ years of related work experience (6+ years with a Master’s).
• 5+ years of clinical research experience.
• Working knowledge of FDA regulations.
• Strong oral and written communication skills.
• Technical writing experience.
• CRA experience and study management experience is a plus.
• Experience with IVD clinical trials preferred.
• Background in infectious diseases or oncology is a plus.
• Ability to manage full scope of studies.

Benefits

• Comprehensive benefits package including health care.
• Paid time off.
• 401(k) plan for eligible employees.
• Bonus/incentive pay eligibility.
• Flexible remote working arrangements.