Oversees all aspects of the regulatory operations for Sarah Cannon site Clinical Operations and manages the regulatory department
Responsible for developing and implementing short
and long-term strategies for regulatory compliance
Ensures Sarah Cannon adheres to and maintains FDA regulatory compliance
Oversees any regulatory audit
Works closely with department directors and/or primary investigators, industry sponsors and other outside entities
Manages, directs, plans and schedules activities and programs for the regulatory department
Establishes and enforces procedures for trial teams and sites compliance
Develops and implements regulatory policies and procedures for the site Clinical Operations team
Manages the regulatory affairs for multiple clinical trials according to FDA and GCP guidelines
Manages relationships between industry partners and the FDA regarding regulatory compliance and auditing

Bachelor's Degree
1+ year work experience with 5+ years' preferred in clinical research corporation and regulatory team
education may be substituted for partial experience
Knowledge of scientific and clinical research terminology
Knowledge of FDA and GCP guidelines
Knowledge of organizational policies, procedures, and systems
Advanced skills with MS Office products including Excel, Word, Outlook
Experience meeting strict deadlines and supervising team members

Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being
Competitive compensation package determined by several factors including performance, experience and skills

Clinical Research Regulatory Affairs Manager

Key skills