Senior Manager / Manager, Clinical Quality

Responsibilities

• Serve as the primary Clinical QA point of contact for a Phase 3, global study
• Collaborate with cross-functional groups to support study start up and execution
• Collaborate with other quality and clinical operations staff on study oversight metric input and review
• Create action plans for metrics
• Use metrics to identify clinical study sites with higher than desired clinical risk and work to mitigate these risks
• Review monitoring reports, primarily focused on outsourced monitoring activities, to identify and mitigate risks
• In collaboration with Clinical Operations, resolve protocol deviations and open action items
• Perform clinical site audits, as needed
• Support clinical site inspection readiness
• Develop and implement procedures for the Priovant Therapeutics Quality Management System (QMS)

Qualifications

• Bachelor's degree in one of the life sciences, or equivalent knowledge and experience
• 6-12 years of experience in biopharmaceutical industry or related field with experience in GCP Quality, experience in additional GXP disciplines a plus
• Ability to audit a variety of operations independently
• Organized and thorough, with attention to details
• Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
• Demonstrated communication, problem-solving, and decision-making skills
• Natural collaborator who enjoys working on a cross-functional team