Clinical Quality Assurance Manager

2 weeks ago

Menlo Park, California, United States Corcept Therapeutics Full time

The Clinical Quality Assurance Manager plays a vital role within the Clinical Quality Assurance (CQA) team, overseeing daily quality operations and compliance measures to ensure the effective execution of clinical trials supported by Corcept Therapeutics.

Key Responsibilities:

  • Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical investigator site evaluations, vendor audits, internal audits of clinical departments, Trial Master File (TMF) assessments, and reviews of pertinent study documentation, including Clinical Study Reports (CSRs).
  • Act as a Quality Assurance representative, providing compliance guidance to clinical study teams.
  • Engage in the review and endorsement of clinical study documents and Standard Operating Procedures (SOPs) related to clinical operations.
  • Ensure adherence to study-specific Audit Plans for assigned programs, utilizing a risk-based methodology for Corcept clinical studies.
  • Evaluate and authorize investigational product (IP) temperature excursions to facilitate timely decisions on IP release or rejection.
  • Drive the continuous enhancement of Clinical Quality Management Systems (CQMS) and processes, including the development and revision of SOPs to uphold GCP compliance and excellence.
  • Prepare and manage inspection readiness activities for GCP.
  • Assist during clinical inspections by regulatory bodies, which may include sponsor inspections, clinical investigator site assessments, and contract research organization (CRO) evaluations.
  • Support inspections related to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Pharmacovigilance (PV).
  • Lead investigations into clinical non-compliance events and implement Corrective and Preventive Actions (CAPA).
  • Conduct quality metric analyses for CQA, including trends in study quality events stemming from clinical process deviations and CAPAs, with a focus on protocol deviations, safety, and other clinical data.
  • Maintain up-to-date knowledge of regulatory agency standards, industry trends, and methodologies pertaining to GCPs, alongside managing the GCP regulatory surveillance program.
  • Provide training and development opportunities for QA team members, mentoring and coaching junior staff as needed.
  • Willingness to travel as required.

Preferred Skills and Qualifications:

  • Comprehensive understanding of Quality Systems that facilitate GCP quality initiatives.
  • Experience in developing GCP processes aligned with industry best practices and training.
  • Proficient in Microsoft Office applications.

Preferred Education and Experience:

  • Bachelor's degree in a scientific discipline or a related field, or equivalent professional experience.
  • A minimum of six years of experience in clinical research.

Compensation for this position is expected to be in the range of $144,800 - $170,300, subject to variation based on factors such as geographic location, relevant skills, experience, and educational background.

Applicants must possess authorization to work in the United States on a full-time basis.

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