Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
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.
Qualifications and Key Success Factors
- 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.
Compensation & Benefits
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.
Company Overview
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. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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Skills Required
- Lead oversight of onsite, remote, and centralized monitoring
- Review monitoring reports and assess site performance
- Collaborate with Clinical Operations, Data Sciences, and QA
- Prepare monitoring oversight reports and CAPA plans
- Support training and mentoring of CRAs and oversight staff
What We Do
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. Praxis is applying insights into the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for rare and more prevalent neurological disorders. 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. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain.
