Remote Senior Clinical Trial Program Lead

Saratoga Ascend; Oregon; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Saratoga Medical is seeking a Remote, Senior Clinical Research Project/Trial Manager to oversee complex NIH- or FDA-regulated studies from start-up through close-out. The role requires a Bachelor's in life sciences or related field, with 5+ years managing regulated trials and leading multidisciplinary teams.

Preferred qualifications include a Master’s degree or certifications (PMP/CCRP/ACRP-CP). Strong leadership, regulatory, and QA experience are essential for success in a dynamic, remote

Qualifications

• Oversight of multi-site or complex clinical trials from start-up through close-out.
• Experience managing task-order or contract deliverables, schedules, budgets and risks.
• Proven ability to coordinate clinical operations, monitoring, data management, regulatory and quality functions.
• Experience with quality assurance oversight, corrective action tracking, and staffing and transition planning.
• Strong leadership, stakeholder communication and Government reporting skills.
• Experience with gene therapy or rare disease studies is advantageous.
• Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs.
• Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA.
• Current human subjects protections and GCP training (e.g., CITI or equivalent).
• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials.

Responsibilities

• Oversee multi-site or complex clinical trials from start-up through close-out.
• Coordinate task-order or contract deliverables, schedules, budgets and risks.
• Lead clinical operations, monitoring, data management, regulatory and quality functions.
• Ensure quality assurance oversight and staffing/transition planning.

Skills

Leadership

Stakeholder communication

Government reporting

Regulatory knowledge

Quality assurance oversight

Cross-functional collaboration

Education

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

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

Job description

Saratoga Medical is seeking a Remote, Senior Clinical Research Project/Trial Manager to oversee complex NIH- or FDA-regulated studies from start-up through close-out. The role requires a Bachelor's in life sciences or related field, with 5+ years managing regulated trials and leading multidisciplinary teams.

Preferred qualifications include a Master’s degree or certifications (PMP/CCRP/ACRP-CP). Strong leadership, regulatory, and QA experience are essential for success in a dynamic, remote