Anja Duke
Cincinnati,OH
Summary
Accomplished Clinical Operations Line Manager at Medpace, adept in regulatory compliance and performance management. Spearheaded training and onboarding initiatives, enhancing team capabilities and productivity. Successfully managed over 20 associates, fostering employee engagement and team building. Proven track record in optimizing resource allocation, driving improvement processes, and ensuring compliance across clinical trials.
Overview
8
8
years of professional experience
Work History
Clinical Operations Line Manager
Medpace
Cincinnati, Ohio
12.2024 - Current
- Manage over 20 associates, including assistants, coordinators, and specialists within the Regulatory Submissions department.
- Execute recruitment, training, development, and resource allocation for associates across the United States.
- Participate in recruitment events and career fairs; serve on interview panels for hiring.
- Assist project managers by establishing performance standards and monitoring compliance.
- Develop and deliver training programs to enhance associate skills and capabilities.
- Monitor capacity and performance of direct reports to ensure optimal productivity.
- Address performance issues as escalation point for project teams regarding individual associates.
- Collaborate weekly with Training and Development department to refine communications and processes.
Regulatory Submissions Coordinator
Medpace
Cincinnati, Ohio
06.2021 - 11.2024
- Distributed and approved essential documentation for trial master file at project initiation.
- Collected and assembled green light packages, ensuring timely site activation with necessary IRB approvals.
- Maintained strict timelines for study start-up and subsequent submissions at both site and study levels.
- Provided guidance to internal and external teams, ensuring compliance with regulations for 15+ clinical trials; working directly with the Regulatory Submissions Manager and Sponsors.
- Developed proactive solutions for clinical trial submission challenges by reviewing relevant regulations.
- Collaborated with cross-functional teams, delivering weekly updates during internal and external meetings.
- Trained CRAs on essential documentation collection to support ongoing project phases.
MAP Graduate Assistant
University of Cincinnati
Cincinnati, Ohio
08.2020 - 05.2021
- Facilitated meetings to evaluate and advise 45 undergraduate students for accelerated master’s program admission.
- Developed an 8-page document for Higher Learning Commission outlining assessment and portfolio reviews of annual program performance.
Peer Leader
Learning Commons
Cincinnati, Ohio
08.2017 - 05.2020
- Guided 23 first year students in adapting to campus through classroom facilitation with specific focuses on University Engagement, Professional and Civic Responsibility, Integrative Learning, and Intellectual and Self-Management topics.
- Orchestrated and expedited an annual community service event to promote inclusion within the greater Cincinnati area.
Family and Friends Intern
Turning Point
London, England
06.2019 - 08.2019
- Networked and recapitulated information at 9 MARAC meetings (high risk DV cases) to promote safety of survivors.
- United with multifarious areas of the company to become more versatile and knowledgeable.
Education
Master of Arts - Psychology
University of Cincinnati, College of Arts & Sciences
Cincinnati, Ohio08.2021
Bachelor of Arts - Psychology, Liberal Arts
University of Cincinnati, College of Arts & Sciences
Cincinnati, Ohio05.2020
Study Abroad -
College Year in Athens
Athens, Greece03.2019
Skills
- Regulatory compliance
- Performance management
- Training and development
- Resource allocation
- Project coordination and management
- Conflict resolution
- Employee engagement and team building
- Improvement processes
Languages
English
Native/ Bilingual
Bosnian
Native/ Bilingual
References
References available upon request.
Timeline
Clinical Operations Line Manager
Medpace
12.2024 - Current
Regulatory Submissions Coordinator
Medpace
06.2021 - 11.2024
MAP Graduate Assistant
University of Cincinnati
08.2020 - 05.2021
Family and Friends Intern
Turning Point
06.2019 - 08.2019
Peer Leader
Learning Commons
08.2017 - 05.2020
Master of Arts - Psychology
University of Cincinnati, College of Arts & Sciences
Bachelor of Arts - Psychology, Liberal Arts
University of Cincinnati, College of Arts & Sciences
Study Abroad -
College Year in Athens