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Senior Manager, Clinical Operations
Cookie InformationLeads clinical operations for multicenter phase 1-4 clinical studies at Lundbeck. Overseeing timelines, budgets, and cross-functional teams to ensure alignment and compliance.
Posted 6/4/2026full-timeRemote • Illinois • 🇺🇸 United StatesSenior💰 $160,000 - $180,000 per yearWebsite
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Leads the planning and execution of multicenter, potentially multinational phase 1-4 clinical studies, while contributing to broader clinical strategy and go-to-market readiness.
- Responsible for the project timelines, budget development and resource planning, and partners cross-functionally to ensure clinical programs are aligned with development objectives, operational excellence, and downstream commercialization needs.
- Ensures timely execution and completion of clinical trials while overseeing study teams and external partners to deliver high-quality clinical trials in compliance with applicable regionals and global regulations.
- Serves as the primary operational lead for assigned studies, with accountability for timelines, budgets, resource planning, and delivery of key milestones.
- Leads cross-functional Study Teams, including CRO/vendor staff, ensuring alignment of clinical execution with broader development strategy.
Requirements
What you’ll need- Accredited Bachelor's Degree
- 5+ years of experience in pharmaceutical, biotech, or CRO industry
- 3+ years of experience in clinical study management or monitoring (e.g., CRA, CTM, Study Manager)
- Demonstrated experience managing global or multicenter clinical trials
- History of managing sites in Pharma-sponsored clinical studies intended for use in NDA applications to FDA including monitoring visit scheduling, clinical site management, site training, site communication, query resolution, and generation of trip reports
- Strong knowledge of the global drug development processes and regulatory requirements (ICH GCP, CFR)
- Excellent written and verbal communication and presentation skills and ability to effectively work on remote cross-functional teams.
- Ability to lead cross-functional teams and influence without direct authority
- Strong project management skills, including planning, prioritization, and risk management
- Ability to manage multiple priorities in a fast-paced, matrixed environment.
Benefits
Comp & perks- flexible paid time off (PTO)
- health benefits to include Medical, Dental and Vision
- company match 401k
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study managementmonitoringproject managementbudget developmentresource planningtimelines managementregulatory complianceglobal drug development processesICH GCPCFR
Soft Skills
written communicationverbal communicationpresentation skillscross-functional team leadershipinfluence without authorityplanningprioritizationrisk managementability to manage multiple prioritiesadaptability
Certifications
Bachelor's Degree