Lead Clinical Study Manager

Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. You will oversee the execution of clinical studies for an assigned clinical program(s) in compliance with quality standards, on schedule and on budget.

Requirements

• BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship, internships, etc.) may be considered to supplement experience requirements.
• 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight.
• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• Demonstrated excellence in project/program management and matrix leadership.
• Excellent communication skills.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and/or long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits