Monitoring Team Lead / Senior Monitoring Team Lead
United Therapeutics Corporation
13 hours ago
Remote
United States
Clinical Research and Development
Responsibilities:
- Plan, implement, and execute clinical monitoring activities for assigned studies; serve as functional lead/POC for central and field monitoring.
- Perform on-site visits, central/analytics data reviews, and site management tasks.
- Establish, execute, and continuously assess clinical monitoring team performance (Clinical Monitoring Plan, enrollment/recruitment plan, data cleaning plan).
- Analyze site trends and monitoring metrics; provide CRA performance feedback and support evaluations.
- Collaborate with cross-functional teams to ensure training on protocols, therapeutic areas, and project systems.
- Create/refine monitoring tools (annotated monitoring visit reports, communication templates, checklists).
- Assist CRAs with significant site issues (e.g., SAE reconciliation, compliance matters, action items).
- Oversee scheduling and execution of monitoring visits; ensure visit documentation review/approval per UTC SOPs.
- Coordinate data cleaning in EDC systems and study portals; own Clinical Monitoring documentation in the eTMF.
- Mentor the monitoring team; conduct training/co-monitoring visits as needed.
Minimum Requirements:
- BS in biological/related life sciences (nursing or relevant clinical research experience may be considered).
- Monitoring Team Lead: 8+ years pharma/biotech/med device/CRO clinical trials; 6+ years CRA monitoring; 1+ year Lead CRA.
- Senior Monitoring Team Lead: 10+ years; 8+ years monitoring; 4+ years study-level oversight/management.
- Experience with eTMF, EDC, IRT, CTMS, and vendor portals; site management capability.
- Knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), GCP, ISO 14155, and clinical trial process.
- Strong communication, time management/organization, attention to detail, and multitasking.
- Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
Location/Travel: Remote (Eastern or Central time zone); up to 20% travel.
Compensation/Benefits: Salary ranges—$105,500-$140,000 (Lead) or $126,500-$165,000 (Senior). Eligible for comprehensive medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off, paid parental leave, disability, and more.
- Plan, implement, and execute clinical monitoring activities for assigned studies; serve as functional lead/POC for central and field monitoring.
- Perform on-site visits, central/analytics data reviews, and site management tasks.
- Establish, execute, and continuously assess clinical monitoring team performance (Clinical Monitoring Plan, enrollment/recruitment plan, data cleaning plan).
- Analyze site trends and monitoring metrics; provide CRA performance feedback and support evaluations.
- Collaborate with cross-functional teams to ensure training on protocols, therapeutic areas, and project systems.
- Create/refine monitoring tools (annotated monitoring visit reports, communication templates, checklists).
- Assist CRAs with significant site issues (e.g., SAE reconciliation, compliance matters, action items).
- Oversee scheduling and execution of monitoring visits; ensure visit documentation review/approval per UTC SOPs.
- Coordinate data cleaning in EDC systems and study portals; own Clinical Monitoring documentation in the eTMF.
- Mentor the monitoring team; conduct training/co-monitoring visits as needed.
Minimum Requirements:
- BS in biological/related life sciences (nursing or relevant clinical research experience may be considered).
- Monitoring Team Lead: 8+ years pharma/biotech/med device/CRO clinical trials; 6+ years CRA monitoring; 1+ year Lead CRA.
- Senior Monitoring Team Lead: 10+ years; 8+ years monitoring; 4+ years study-level oversight/management.
- Experience with eTMF, EDC, IRT, CTMS, and vendor portals; site management capability.
- Knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), GCP, ISO 14155, and clinical trial process.
- Strong communication, time management/organization, attention to detail, and multitasking.
- Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
Location/Travel: Remote (Eastern or Central time zone); up to 20% travel.
Compensation/Benefits: Salary ranges—$105,500-$140,000 (Lead) or $126,500-$165,000 (Senior). Eligible for comprehensive medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off, paid parental leave, disability, and more.