Manage complex, multi-site NIH- and FDA-regulated clinical trials from start-up through close-out. Lead multidisciplinary teams and coordinate clinical operations, monitoring, data management, regulatory, quality assurance, budgets, schedules, risks, deliverables, corrective actions, staffing, transitions, stakeholder communications, and government reporting. Ensure compliance with GCP, applicable FDA and NIH regulations, human subjects protections, and HIPAA.
Saratoga Medical is hiring a Remote, Senior Clinical Research Project / Trial Manager. Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
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.
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