Job Description
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. 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 Apply tot his job