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Manager, Center Clinical Research jobs in United States
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Northwestern University · 1 day ago

Manager, Center Clinical Research

Northwestern University is part of the Feinberg School of Medicine and is seeking a Manager for the Center for Clinical Research. This role is integral to advancing clinical research operations, regulatory compliance, and financial management, while also leading workforce development initiatives and fostering collaboration across various partners.
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H1B Sponsor Likelynote

Responsibilities

Oversee and manage all operations within the Center for Clinical Research, including regulatory, finance, and staffing to support study start up, regulatory compliance, and participant management
Lead and collaborate with internal and external partners on best practices, knowledge sharing, professional development, and NUCATS initiatives. Serve as liaison to external CTSA professionals through collaborations and research initiatives
Collaborate with investigators, IRB, and other school and university units to support regulatory compliance, protocol needs, and internal and external regulators (e.g. FDA, IRB, ClinicalTrials.gov)
Facilitate FDA IND/IDE regulatory needs by providing departments with appropriate resources and contacts to third party vendor
Manage financial aspects of appropriate clinical research projects, including budget negotiation, contract facilitation, billing and cost recovery, and monitoring financial performance. Align CCR finance and regulatory teams with school, university, and sponsor requirements
Manage projects and process improvement using metrics-based evaluation, including study start up times, participant recruitment and retention, by developing, implementing, and collaborating on standards of operations, quality improvement, and project management
Provide project management oversight for the Trial Innovation Network, CTSA collaboration sites, and other strategic initiatives within NUCATS, coordinating timelines, resources, projects, and stakeholder engagement for multicenter clinical trials and center-wide projects
Miscellaneous Performs other duties as assigned

Qualification

Clinical research managementRegulatory affairsFinancial oversightBudget managementFDA IND/IDE knowledgeProject managementInterpersonal skillsLeadership skillsCollaboration skillsOrganizational skills

Required

5+ years of managerial experience in clinical trials
Demonstrated experience managing budgets, staffing, and operational planning across multiple service lines
Proven ability to multitask and prioritize deadlines in a highly matrixed environment
Strong background in regulatory affairs, including IRB compliance and human subjects research protections
Excellent communicator with strong interpersonal and leadership skills
Growth-oriented mindset with the ability to manage multiple high-level initiatives simultaneously
Strong ability to collaborate across groups
Must work well in a team-oriented environment and collaborate closely with others
Well-organized with ability to handle multiple projects simultaneously
Ability to interact well with program participants: investigators, administrators, faculty, and research stakeholders

Preferred

ACRP or SoCRA certification required
Experience working with multisite clinical trials, including coordination, oversight, and regulatory alignment across institutions
Familiarity with FDA Investigational New Drug (IND)/Investigational Device Exemption (IDE) applications and related regulatory processes is preferred

Benefits

High-quality health care plans
Retirement benefits
Tuition discounts
Flexible work arrangements
Programs to help you locate and pay for quality, affordable childcare and senior/adult care
Employee career development

Company

Northwestern University

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Northwestern University is a private research and teaching university that offers academic programs across various fields of study. It is a sub-organization of Northwestern Athletics.

H1B Sponsorship

Northwestern University has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (325)
2024 (308)
2023 (280)
2022 (282)
2021 (184)
2020 (155)

Funding

Current Stage
Late Stage
Total Funding
$98.02M
Key Investors
National Peanut BoardAdvanced Research Projects Agency for HealthGRAMMY Museum
2024-10-30Grant
2024-10-04Grant· $34M
2023-11-28Grant· $0.02M

Leadership Team

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Diego Klabjan
Professor
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Henry Bienen
Interim President
Company data provided by crunchbase