Senior Clinical Research Project / Trial Manager

Saratoga Medical Center; United States; À distance; USD 120 000 - 160 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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

Connaissances

Multi-site oversight

Deliverables mgmt

Regulatory coordination

Quality assurance

Leadership

Stakeholder communications

Government reporting

Gene therapy

NIH/FDA regulation

GCP training

Teamwork

Formation

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

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

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Clinical Research Project / Trial Manager

Full Time Remote, US

Saratoga Medical is hiring a Remote, Senior Clinical Research Project / Trial Manager. Package includes competitive rate and benefit options.

Education: Bachelor's degree in life sciences, nursing, public health or a related field required; master's degree or PMP/CCRP/ACRP-CP certification preferred.

Experience: Minimum of 8 years of clinical research experience, including at least 5 years managing NIH- or FDA-regulated studies and leading multidisciplinary teams.

Qualifications:

• Demonstrated 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

Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.