Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Senior Manager, Clinical Operations will help forward this mission by proactively managing program-level operational aspects of global clinical trials including managing CRAs, developing study operational plans, conducting onsite initiation, and monitoring visits, and tracking key clinical quality indicators.

Responsibilities

• Manage Priovants in-house CRAs on key clinical programs.
• Develop high-quality study operational manuals and plans, including a Clinical Monitoring Plan and Protocol Deviation Handling Guide. Oversee adherence to those plans.
• Review and participate in the development of study protocols, informed consent forms, pharmacy manuals, eCRF entry manuals, eTMF and filing plans, and other study plans and guidance.
• Review IP release checklists, protocol deviations, aging action items, critical query and query aging, and other clinical trial operational data. Identify issues and implement solutions.
• Review and approve monitoring trip reports.
• Perform onsite visits with CRAs, including site initiation visits and site interim monitoring visits.
• Lead content development and delivery for study clinical operations trainings, including CRA training, study coordinator training, investigator meeting training, and SIV training.
• Participate in site feasibility and selection processes by reviewing site qualifications and assessing facility, staff qualifications, and site ability to conduct the protocol.
• Ensure timely document collection and filing in our eTMF. Administer and control access, file documentation and perform QC.
• Lead real-time storyboard creation in partnership with Quality Assurance as part of our inspection readiness program.
• Develop Key Clinical Quality Indicators that provide insights on and identify risks related to clinical monitoring activities and site protocol adherence. Implement weekly monitoring of these indicators and a process for elevating and resolving items proactively.
  
  

Qualifications:

• 8+ years clinical operations experience, including experience directly managing CRAs
• Experience with, and command of, all key aspects of clinical trial operations
• Ability to prioritize, organize, plan, and achieve results on multiple projects simultaneously.
• Self-starter with a strong sense of ownership and ability to work autonomously.
• Desire to work in a lean, fast-paced, nimble environment; comfort with associated uncertainty and rolling up your sleeves to get things done.
• BA/BS degree or equivalent