Quality Recruiting. Established Experts.

Associate Director Clinical QA

Reference Number: 3196
Location: Southern New England

Our client is an emerging biotechnology company. They have asked us to assist them in their search for an Associate Director Clinical QA.

 Major tasks and responsibilities will include:

  • Participates with the clinical team in the clinical project set-up.
  • Reviews processes, identifies risks and reviews mitigation plans.
  • Acts as a consultant in operational meetings.
  • Reviews monitoring reports, follows up on and ensures closure of monitoring issues.
  • Creates, maintains and reports quality metrics and signals.
  • Revises the Quality Audit Program based on compliance risks identified.
  • Plans, prepares for, performs, reports and closes Investigator Site Audits.
  • Monitors and reports CRA performance.
  • Initiates, manages and closes quality issues.
  • Consults, assesses and approves investigations, root cause analysis and CAPA and confirm efficiency.
  • Creates and oversees Continuous Improvement Plan (CIP).
  • Maintains the Investigator Compliance Database.
  • Provides quarterly Lessons Learned training modules for CRAs and clinical team.
  • Creates and reports quality and compliance metrics.
  • Creates and reports performance metrics.
  • Updates the Risk Log.
  • Improves QA and Compliance systems and procedures.
  • Sets-up with the clinical team the structure of the TMF.
  • Works with multiple clinical sites, CROs and CRAs to collect, QC, verifies and archives clinical documents.
  • Tracks TMF completeness and provides performance and quality metrics.
  • Points of contact for anything regarding clinical trial documentation.
  • Provides appropriate regulatory documents to regulatory affairs for submission to FDA or other regulatory agencies as needed.

We seek candidates with the following qualifications:

  • A minimum of 6 years of Clinical Quality Assurance and Compliance experience is needed.
  • This person must have a deep knowledge of TMF structure and contents (DIA reference model).
  • This person must have experience in Regulatory inspections.
  • Excellent understanding of drug development and clinical operations is a must.
  • Ability to influence without authority.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3196. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.