Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Manager / Senior Manager, Clinical Quality will help advance this mission by ensuring complete and compliant documentation of clinical study activities. S/he will also assist in developing Quality Systems and executing within these systems across Priovant's clinical development programs. S/he will report to the Director, Quality.
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)
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
Originally posted by Priovant Therapeutics. View original posting
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