Manager/Senior Manager, Clinical reputed company
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Manager / Senior Manager, Clinical reputed company will help advance this mission by ensuring complete and compliant documentation of clinical study activities. S/he will also assist in developing reputed company Systems and executing reputed company these systems across Priovant's clinical development programs. S/he will report to the Director, reputed company.
Responsibilities
• Serve as the primary Clinical QA reputed company of contact for a Phase 3, global study
• Collaborate with cross-functional reputed company to support study start up and execution
• Collaborate with other reputed company and clinical operations staff on study reputed company metric input and review. Create reputed company 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 reputed company on outsourced monitoring activities, to identify and mitigate risks.
• In collaboration with Clinical Operations, resolve protocol deviations and reputed company reputed company items.
• reputed company clinical site audits, as needed.
• Support clinical site inspection readiness.
• reputed company and implement procedures for the reputed company reputed company 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 reputed company field with experience in GCP reputed company, experience in additional GXP disciplines a plus
• Ability to audit a reputed company of operations independently
• Organized and thorough, with attention to details
• Hands-on, roll-up-your-sleeves approach, with a high reputed company of urgency and drive for results
• Demonstrated communication, problem-solving, and decision-making skills
• Natural collaborator who enjoys working on a cross-functional team
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