Monitoring Oversight Lead
Praxis Precision Medicines, Inc.
16 days ago
Remote friendly (Boston, MA)
United States
Operations
Location/Travel: This position may be performed remotely, but requires flexibility and willingness to travel as needed.
The Opportunity
As Monitoring Oversight Lead, you will help ensure clinical studies are conducted to the highest standards by developing and managing strategies that keep trial data accurate, compliant, and inspection-ready.
Responsibilities
- Lead oversight of onsite, remote, and centralized monitoring across clinical programs.
- Review monitoring reports; assess site and CRA performance; identify trends/issues early.
- Collaborate with Clinical Operations, Data Sciences, QA, and CRO partners (as applicable) to improve trial execution.
- Conduct risk assessments and develop proactive issue-detection and prevention strategies.
- Prepare monitoring oversight reports and CAPA plans.
- Support ongoing training and mentoring of CRAs, oversight staff, and vendor teams.
- Ensure inspection and audit readiness for monitoring activities.
Qualifications / Key Success Factors
- Experience leading monitoring oversight (onsite/remote/centralized) in clinical programs.
- Ability to perform risk assessments and drive proactive quality strategies.
- Strong ability to produce clear, actionable oversight reporting and CAPA plans.
Compensation & Benefits
- Annualized Base Salary: $180,000–$200,000 USD.
- Benefits include 99% premium paid for medical/dental/vision; company-paid life insurance, AD&D, disability; voluntary plans; 401(k) match up to 6%; long-term stock incentives and ESPP; discretionary quarterly bonus; flexible wellness benefit; generous PTO; paid holidays and company-wide shutdowns.
The Opportunity
As Monitoring Oversight Lead, you will help ensure clinical studies are conducted to the highest standards by developing and managing strategies that keep trial data accurate, compliant, and inspection-ready.
Responsibilities
- Lead oversight of onsite, remote, and centralized monitoring across clinical programs.
- Review monitoring reports; assess site and CRA performance; identify trends/issues early.
- Collaborate with Clinical Operations, Data Sciences, QA, and CRO partners (as applicable) to improve trial execution.
- Conduct risk assessments and develop proactive issue-detection and prevention strategies.
- Prepare monitoring oversight reports and CAPA plans.
- Support ongoing training and mentoring of CRAs, oversight staff, and vendor teams.
- Ensure inspection and audit readiness for monitoring activities.
Qualifications / Key Success Factors
- Experience leading monitoring oversight (onsite/remote/centralized) in clinical programs.
- Ability to perform risk assessments and drive proactive quality strategies.
- Strong ability to produce clear, actionable oversight reporting and CAPA plans.
Compensation & Benefits
- Annualized Base Salary: $180,000–$200,000 USD.
- Benefits include 99% premium paid for medical/dental/vision; company-paid life insurance, AD&D, disability; voluntary plans; 401(k) match up to 6%; long-term stock incentives and ESPP; discretionary quarterly bonus; flexible wellness benefit; generous PTO; paid holidays and company-wide shutdowns.