What are the responsibilities and job description for the Clinical Project Manager position at Monopar Therapeutics Inc.?
Monopar’s Clinical Operations team is growing! We are excited to add an experienced Clinical Project Manager with proven track record of success. Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs. This role will focus on our drug candidate for Wilson Disease that has progressed through a Phase 3 clinical trial, meeting its primary endpoint.
What you’ll do…
- Contribute to regulatory new drug applications (e.g., NDA, MAA)
- Review documents and data for submission readiness; develop and execute strategies to address issues.
- Conceptualize, plan, design, and execute clinical summaries, including ISS and ISE
- Drive vendor management, including collaboration with Study Medical Monitor and KOLs to determine the medical and scientific needs
- Effectively communicate project-related information including the planning and execution of meetings and presentations as well as creation and maintenance of metrics, e.g., dashboards, timelines, resources, and budgets
- Identify issues and propose solutions. Proactively assess potential risks and propose mitigation plans
- Work in an office (Wilmette, IL north of Chicago) with a dynamic, talented team
What skills & experience you’ll bring to us…
- 3 years’ experience as a CPM following progressively responsible positions in pharmaceutical or biotechnology company’s clinical department conducting clinical trials from monitoring to project management
- Authored multiple clinical study reports
- Successfully closed multiple clinical studies, including closure of the related TMFs
- Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA), and European regulations
- Excellent communication (oral and/or written), leadership, and risk mitigation skills plus a positive attitude
- Require minimal guidance; is able to function in an independent manner
- Proven ability to effectively manage internal and external personnel in clinical trial conduct
- Demonstrated ability to plan and execute Pharma-Sponsored clinical trials, managing vendors and resources in effective & creative manners to achieve business needs including on-time, on-budget, and on-spec study results for successful use in regulatory marketing applications
- Preferred Experience: small or growth-stage biopharma company; data management experience; oncology trials in Europe or Australia; 7 years’ clinical trial experience
