Clinical Compliance Lead-Quality Assurance

1 week ago

Remote, Oregon, United States Advarra Consulting Full time

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Company Information

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.

Company Culture

Our people-both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

Job Overview Summary

This full-time remote position, overseeing the Quality Management System, is estimated to start in December and last for six months (with an option to extend).

Job Duties & Responsibilities

  • Ensures all clinical operations comply with global regulatory requirements, ICH-GCP guidelines.
  • Evaluate, revise or create company standard operating procedures (SOPs).
  • Act as a key liaison between the Clinical Quality team and cross-functional study teams.
  • Manage documentation, audits, CAPAs, and vendor qualification processes within the Veeva QMS platform.

Location

This role is open to candidates working remote in the United States.

Basic Qualifications

  • Proven expertise creating and managing Clinical QMS
  • Auditing expertise and management
  • Has held a similar position, Asst. Director level or above
  • Expertise in ICH-GCP and E6 R3 guidelines
  • Evaluation and Creation of Clinical SOP's
  • Vendor qualification experience
  • CAPA experience
  • Experience acting as a liaison between the Clinical Quality team and cross-functional study teams

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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