Senior Manager, Clinical Operations

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Leads 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

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Hard Skills

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 & Qualifications

Bachelor's Degree

Industry Keywords

pharmaceuticalbiotechCROmulticenter clinical trialsNDA applicationsclinical site managementsite trainingsite communicationquery resolutiontrip reports

Tech Stack

Tools & technologies

Google 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