Northwestern University · 11 hours ago
Senior Clinical ResearchProject Manager
Chicago, IL
Full-time
Onsite
Senior Level
$70K/yr - $98K/yr
5+ years expNorthwestern University is a leading academic institution, and they are seeking a Senior Clinical Research Project Manager. The role involves managing complex biomedical and social-behavioral research studies, ensuring compliance with protocols, and leading cross-functional teams to meet study objectives.
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Responsibilities
Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities
Serve as the main start up point of contact for both internal and external stakeholders
Take oversight of development and implementation of the start-up strategy with cross functional teams
Provides support to the other project managers around feasibility and financial resourcing tasks during the start up phase
Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules
Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule
Plan, conduct and close out of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)
Lead cross functional study team, Disease Team Meetings, actively manage and track study milestones and critical path activities
Provide regular updates on study status and progress to cross functional teams, stakeholders, and governance bodies
Development of the clinical study design and associated systems and documents; ICF, eCRF, IRT, CSR, etc
Proactively anticipate, identify, and address study related issues and opportunities for innovative solutions and best practices
Single point of contact and decision maker for operational aspects of the study
Point of escalation for any study activation feasibility issues
Initiate and actively participate in creation of innovative solutions and process improvement initiatives beyond his/her studies
Responsible for quality control and inspection readiness at all times
Responsible for risk assessment, mitigation planning and execution
Prepare, oversee, and review documents that are related to assigned clinical study (NDA, etc.)
Arrange or help in organizing clinical study meetings, as necessary
Ensure the availability of necessary resources for the execution of clinical projects
Answerable to questions and issues brought up by vendors and external consultants
Oversee the pattern and manner in which clinical research study is being conducted
Fully involved in resolving issues; take part in procedure improvement initiatives
Track logistics of samples and communicate those results effectively with the data analysts, etc
Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
Work hand-in-hand with clinical trial managers and document control personnel to manage documents that are related to the clinical study
Analyzes, evaluates & interprets data to determine relevance to research
Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc
Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions
Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner
Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports
Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data
Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines
Ensures appropriate allocation & compliance
Coordinates & participates in budgetary negotiations with industry sponsors
Acts as a mentor in regard to education of junior coordinators and project managers
Performs other duties as assigned
Qualification
Required
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; OR
Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience
Supervisory Or Project Management Experience Required
Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance)
2-3 years relevant leadership/management experience
Minimum 2 years of relevant experience with successful delivery of project study start-up
Preferred
Preferred exposure in study initiation through study completion in multiple phases of studies (Phase 1-3, 4)
Benefits
Meaningful, competitive, high-quality health care plans
Retirement benefits
Tuition discounts
Comprehensive programs and services to help you and your family navigate life’s challenges and opportunities
Flexible work arrangements
Programs to help you locate and pay for quality, affordable childcare and senior/adult care
Employee career development
Variety of tools and resources
Company
Northwestern University
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.
5001-10000 employees
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 StageTotal Funding
$98.02MKey Investors
National Peanut BoardAdvanced Research Projects Agency for HealthGRAMMY Museum
2024-10-30Grant
2024-10-04Grant· $34M
2023-11-28Grant· $0.02M
Leadership Team
Diego Klabjan
Professor
Henry Bienen
Interim President
Recent News
2026-01-25
Digital Journal
2026-01-23
Company data provided by crunchbase