Remote Senior Clinical Research Project Leader

Saratoga Medical Center; United States; Remote; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Saratoga Medical Center is seeking a Remote Senior Clinical Research Project / Trial Manager to lead complex NIH- or FDA-regulated studies across multiple sites, from startup through close-out. This full-time remote role requires a strong background in life sciences and clinical operations.

The ideal candidate has at least 8 years in clinical research, 5+ years managing regulated studies, and proven ability to manage budgets, schedules and cross-functional teams.

Qualifikationen

• Bachelor’s degree in life sciences, nursing, public health or related field required.
• Master’s degree or PMP/CCRP/ACRP-CP certification preferred.
• Minimum 8 years of clinical research experience, including 5+ years managing NIH- or FDA-regulated studies.
• Experience leading multidisciplinary teams.
• GCP and regulatory knowledge (ICH E6, 21 CFR Part 11, 50, 54, 56, 312, 812) and related protections.

Aufgaben

• Oversight of multi-site or complex clinical trials from start-up through close-out
• Coordinate task orders, schedules, budgets and risks
• Coordinate clinical operations, monitoring, data management, regulatory and quality functions
• Quality assurance oversight, corrective action tracking, staffing and transition planning
• Leadership and government reporting

Kenntnisse

Multi-site oversight

Deliverables mgmt

Regulatory coordination

Quality assurance

Leadership

Stakeholder communications

Government reporting

Gene therapy

NIH/FDA regulation

GCP training

Teamwork

Ausbildung

Bachelor's degree in life sciences, nursing, public health or related field

Master's degree or PMP/CCRP/ACRP-CP certification preferred

Jobbeschreibung

Saratoga Medical Center is seeking a Remote Senior Clinical Research Project / Trial Manager to lead complex NIH- or FDA-regulated studies across multiple sites, from startup through close-out. This full-time remote role requires a strong background in life sciences and clinical operations.

The ideal candidate has at least 8 years in clinical research, 5+ years managing regulated studies, and proven ability to manage budgets, schedules and cross-functional teams.