Clinical Quality Assurance Manager

4 weeks ago

Reston, Virginia, United States Advanced Clinical Full time

Manager of Clinical Quality

Location: Palo Alto area

Hybrid - 3 days onsite

Overview

We are currently seeking a skilled professional to join our team as a Manager, GCP Quality Assurance. This hybrid role will collaborate with cross-functional teams on deliverables and provide GCP and compliance-related advice to Internal Clinical Study teams. Your work will have a direct impact on the organization and the larger clinical industry, making this an exciting career opportunity.

Responsibilities

  • Identify and prioritize audit strategies for GCP programs
  • Coordinate, plan, and/or conduct clinical study-related audits (Investigator Sites, Clinical Service Providers, Internal Systems, etc.)
  • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
  • Conduct training for staff (GCP, Inspection Readiness training, etc.)
  • Interview, select, and train employees
  • Prepare and host regulatory inspections
  • Write and review Standard Operating Procedure (SOPs)

Requirements

  • Minimum of 6 years of experience in FDA- and ICH-regulated clinical research in GCP QA required
  • Formal leadership experience preferred
  • Oncology experience desired
  • Detailed knowledge of and ability to interpret/apply GCP, EU, FDA, and ICH regulations/guidelines
  • Ability to critically analyze and communicate compliance-related information and present associated risks
  • Ability to coordinate internal/contract auditors and conduct audits
  • Experience auditing Investigator sites, Clinical Service Providers, and Internal Systems Audits
  • Experience with regulatory inspection and inspection readiness
  • Experience with Quality Management Systems
  • Experience reviewing study-related documentation (protocols, clinical study reports, informed consents) and communicate findings to appropriate team members
  • Ability to work independently, manage multiple priorities, and execute on goals
  • Excellent interpersonal and written communication skills
  • Strong analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Travel required – up to 25% (domestically and internationally)

Education

  • Minimum of Bachelor's Degree in a scientific discipline required

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical, visit our website.

Equal Employment Opportunity

Advanced Clinical is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment and do not discriminate on the basis of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law.

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