Senior Manager, Clinical Operations

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