Senior Manager / Associate Director, Clinical Operations
- Manage Priovant's 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.
- 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
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