Alayna Ware
Covington,KY
Summary
Results-driven Senior Clinical Operations Line Manager with over 6.5 years of CRO based experience focused on successful study start-up, regulatory submission strategy, and cross-functional trial execution for Phase I-IV studies. Collaborative and engaged leader with a passion for building, mentoring, and developing high-performing teams.
Overview
7
7
years of professional experience
Work History
Senior Clinical Operations Line Manager
Medpace
Cincinnati, OH
01.2025 - Current
- Lead a team of 25 Study Start-Up Coordinators and an additional 20 indirect reports providing consistent oversight and study start-up strategy support.
- Directly manage and mentor a Clinical Operations Line Manager, overseeing onboarding, training, and ongoing coaching to support effective team leadership and development.
- Oversee daily operations across study start-up teams, ensuring compliance with ICH-GCP, adherence to start-up timelines, timely regulatory submissions, and alignment with Sponsor expectations.
- Design and implement structured training programs that strengthen team performance, support career development, and promote continued skill growth.
- Lead full-cycle recruitment efforts, including participation in recruitment events, candidate interviews, and hiring decisions to support the growth of high-performing teams.
- Develop and lead team engagement initiatives that foster collaboration, strengthen team connections, and support a positive team culture.
- Provide broader leadership and strategic oversight following promotion, while maintaining core responsibilities from the previous role.
Clinical Operations Line Manager
Medpace
Cincinnati, OH
06.2022 - 01.2025
- Led a team of 20 Study Start-Up Coordinators ensuring high-quality onboarding experiences and consistent operational performance.
- Manage comprehensive training and peer mentorship program during onboarding and throughout career, enhancing team productivity and overall effectiveness.
- Monitor individual contributor capacity, utilization, and performance metrics to optimize resource allocation.
- Conduct biannual performance reviews, setting clear objectives and providing actionable feedback aligned with individual development goals.
- Collaborate with operational management team to support individual performance in alignment project goals and to improve study start-up efficiency.
Study Start-Up Coordinator
Medpace
Cincinnati, OH
10.2019 - 06.2022
- Led study start-up and post-activation activities for 15+ clinical trials across multiple therapeutic areas, including oncology, cardiology, gene therapy, rare disease, and medical device studies.
- Served as a primary contact for research sites, Sponsors, and vendors, providing guidance on start-up strategy, resolving issues, and supporting timely site activation.
- Oversaw initial, amendment, and continuing review submissions with Central IRBs (WCG and Advarra), ensuring accurate, timely submissions that aligned with Sponsor and site requirements.
- Provided oversight of the development, review, and negotiation of Informed Consent Forms (ICFs), ensuring alignment with protocol requirements, regulatory standards, and patient protection considerations.
- Oversaw the preparation and validation of site activation (Greenlight) packages, supporting site readiness and timely study initiation.
- Documented and communicated regulatory updates to internal and external stakeholders, proactively identified timeline risks, and partnered across teams to resolve issues and keep study milestones on track.
- Partnered with research sites to collect, review, and maintain accurate essential documents throughout study start-up and ongoing study operations.
- Oversaw TMF quality reviews and reconciliation activities to support document completeness, compliance, and audit readiness.
- Mentored and supported junior regulatory staff, providing guidance on processes, expectations, and day-to-day study activities.
Education
Bachelor of Science - Public Health, Community Health
Eastern Kentucky University
Richmond, KY12-2018
Skills
- Team Leadership & Development
- Multi-Therapeutic Regulatory Experience
- ICH-GCP Compliance
- Study Start-Up Oversight
- Talent Acquisition & Onboarding
- Cross-Functional Collaboration
- Regulatory Metrics & Performance Tracking
Affiliations
For Goodness Cakes, Cincinnati/NKY Chapter
Active Member
March 2023 to Present
Active Member
March 2023 to Present
Timeline
Senior Clinical Operations Line Manager
Medpace
01.2025 - Current
Clinical Operations Line Manager
Medpace
06.2022 - 01.2025
Study Start-Up Coordinator
Medpace
10.2019 - 06.2022
Bachelor of Science - Public Health, Community Health
Eastern Kentucky University