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.
Similar Jobs
Information Technology • Cybersecurity
Leads the global Revenue Readiness function for a scaling B2B SaaS organization. Sets strategy, governance, operating standards, learning infrastructure, readiness measurement, and multi-year roadmaps. Partners with senior GTM leaders and cross-functional teams to prepare sellers and managers for launches, process changes, and evolving sales expectations. Builds and develops the readiness team, manages priorities and resources, and uses data and AI-supported workflows to improve preparedness, adoption, reinforcement, and business execution.
Top Skills:
Artificial Intelligence (Ai)Digital Sales RoomsLearning Management Systems (Lms)MeddpiccMutual Action Plans
Fintech • Legal Tech • Software • Financial Services • Cybersecurity • Data Privacy
Sources and launches new partnership channels with MSSPs and security firms. Builds relationships through outbound networking, pitches joint go-to-market solutions, enables partners with training and technical resources, and tracks partner engagement, deployment milestones, and ecosystem growth. The role requires cybersecurity ecosystem familiarity, technical integration knowledge, solution-oriented planning, and strong presentation and relationship-building skills.
Top Skills:
Cloud ComputingCybersecurityDigital Infrastructure
Information Technology • Cybersecurity
Owns joint go-to-market and channel marketing plans with North American reseller partners. Executes demand generation campaigns, webinars, events, product launches, co-marketing programs, and MDF-funded activities. Develops partner-ready campaigns and materials, coordinates with sales and product marketing, tracks pipeline and campaign KPIs, measures ROI, supports partner engagement, and recommends improvements to channel programs and enablement.
Top Skills:
CRMHubspotMarketing AutomationPartner Portal ToolsPrmSalesforce
What you need to know about the Colorado Tech Scene
With a business-friendly climate and research universities like CU Boulder and Colorado State, Colorado has made a name for itself as a startup ecosystem. The state boasts a skilled workforce and high quality of life thanks to its affordable housing, vibrant cultural scene and unparalleled opportunities for outdoor recreation. Colorado is also home to the National Renewable Energy Laboratory, helping cement its status as a hub for renewable energy innovation.
Key Facts About Colorado Tech
- Number of Tech Workers: 260,000; 8.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lockheed Martin, Century Link, Comcast, BAE Systems, Level 3
- Key Industries: Software, artificial intelligence, aerospace, e-commerce, fintech, healthtech
- Funding Landscape: $4.9 billion in VC funding in 2024 (Pitchbook)
- Notable Investors: Access Venture Partners, Ridgeline Ventures, Techstars, Blackhorn Ventures
- Research Centers and Universities: Colorado School of Mines, University of Colorado Boulder, University of Denver, Colorado State University, Mesa Laboratory, Space Science Institute, National Center for Atmospheric Research, National Renewable Energy Laboratory, Gottlieb Institute
