Senior Clinical Research Project, Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise multi-site or intricate clinical trials from initiation through completion

• Oversee task-order or contract obligations, timelines, budgets, and risk management

• Facilitate clinical operations, monitoring, data management, regulatory compliance, and quality assurance functions

• Ensure quality assurance supervision and monitor corrective action implementations

• Assist with staffing and transition strategies

• Lead cross-functional teams and collaborate with Government clinical investigators, regulatory personnel, and program officials

• Manage communication with stakeholders and handle Government reporting

⛳️ Requirements

• A Bachelor's degree in life sciences, nursing, public health, or a related discipline is required

• A minimum of 8 years of experience in clinical research is necessary

• At least 5 years of experience managing NIH- or FDA-regulated studies and leading cross-disciplinary teams

• Proven track record of overseeing multi-site or complex clinical trials from onset to conclusion

• Experience in managing task-order or contract deliverables, timelines, budgets, and risk assessments

• Established ability to coordinate clinical operations, monitoring, data management, regulatory compliance, and quality assurance

• Experience with quality assurance oversight, tracking corrective actions, and planning for staffing and transitions

• Exceptional leadership abilities, stakeholder communication, and Government reporting skills

• Familiarity with Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 (as applicable), 45 CFR Part 46, and HIPAA regulations

• Current training in human subjects protections and GCP (e.g., CITI or equivalent)

• Experience working within a multidisciplinary team alongside Government clinical investigators, regulatory staff, and program officials

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

• Experience with gene therapy or studies involving rare diseases is a plus

🏝️ Benefits

• Competitive compensation

• Variety of benefit options