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