Clinical Quality Manager

View full description

Requirements:

• Bachelor’s degree or equivalent experience in animal science, biology, veterinary, or related life sciences.
• 5+ years experience in GCP/PV, clinical development, or QA.
• Excellent communication, presentation, and interpersonal skills.
• Exceptional organizational and follow-up skills, with strong attention to detail.
• Ability to travel up to 40% regionally and nationally.
• Working knowledge of regulations for Good Laboratory Practice and Good Clinical Practice.
• Proficiency in electronic data capture systems and study drug inventory management systems.
• Ability to analyze complex problems and develop solutions within regulatory guidance.

Responsibilities:

• Own data quality generated in pre-clinical and clinical studies.
• Implement quality assurance and control processes per GLP, GCP, and regulatory requirements.
• Lead quality initiatives and collaborate with cross-functional teams, including biostatistics and clinical operations.
• Build and implement systems for data integrity throughout long studies.
• Support clinical operations and biostatistics teams to maximize data retention.
• Lead development of quality control programs and conduct site visits with CRAs.
• Identify and manage discrepancies in data collection, providing training if needed.
• Develop risk-based audit plans and oversee deviation root cause analysis.