This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This position may be performed remotely, but requires the flexibility and willingness to travel as needed. At Praxis, we turn neuroscience discoveries into treatments to improve patients’ lives. As our Monitoring Oversight Lead, you’ll play a key role in making sure our studies are conducted to the highest standards. You’ll develop and manage strategies that keep trial data accurate, compliant, and inspection-ready, while helping our sites and partners perform at their best. - Lead oversight of onsite, remote, and centralized monitoring across our clinical programs. - Review monitoring reports, assess site and CRA performance, and identify trends or issues early. - Collaborate closely with Clinical Operations, Data Sciences, QA, and CRO partners, if applicable, to drive excellence in trial execution. - Perform risk assessments and develop proactive strategies for issue detection and prevention. - Prepare clear, actionable monitoring oversight reports and CAPA plans. - Support ongoing training and mentoring of CRAs, oversight staff, and vendor teams. - Ensure inspection and audit readiness for all monitoring activities. The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Qualifications - Lead oversight of onsite, remote, and centralized monitoring across our clinical programs. - Review monitoring reports, assess site and CRA performance, and identify trends or issues early. - Collaborate closely with Clinical Operations, Data Sciences, QA, and CRO partners, if applicable, to drive excellence in trial execution. - Perform risk assessments and develop proactive strategies for issue detection and prevention. - Prepare clear, actionable monitoring oversight reports and CAPA plans. - Support ongoing training and mentoring of CRAs, oversight staff, and vendor teams. - Ensure inspection and audit readiness for all monitoring activities. Benefits - 99% of the premium paid for medical, dental and vision plans. - Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize coverage. - Dollar-for-dollar match up to 6% on eligible 401(k) contributions. - Long-term stock incentives and ESPP. - Discretionary quarterly bonus. - Extremely flexible wellness benefit. - Generous PTO, paid holidays, and company-wide shutdowns. - Joining a phenomenal crew of colleagues who are smart, engaged, and inspiring. Company Description Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. - Core Values: Trust, Ownership, Curiosity, and Results. - Guided by our core values, we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion. - Equal opportunity employer committed to providing opportunities to all qualified applicants.