What are the responsibilities and job description for the Clinical Project Lead position at firstPRO, Inc?
firstPRO is now accepting resumes for a Clinical Quality Compliance Lead in Cambridge, MA. This is a 12 month contract and onsite 2 days a week.
OBJECTIVES/PURPOSE:
• Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
• Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.
• Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to the company’s values and strategic priorities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.
