Alysha McDonald
Wendell
Summary
Dynamic program operations manager with a proven ability to deliver impactful results through strategic project management and strong leadership. Expertise in fostering collaboration and optimizing resources to enhance operational efficiency. Recognized for effective communication skills that facilitate stakeholder engagement and drive team success.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Program Director, Global Project Management
Celerion, Inc
04.2025 - Current
- In addition to the Global Project Manager responsibilities, acts as the bridge between strategic vision and operational execution for over 6 different compounds, ensuring that programs are well-planned, effectively managed, and deliver on sponsor objectives.
- Identify potential risks and challenges that could impact program success and develop strategies to mitigate them.
- Drives project execution by holding core team members accountable and ensuring cross-functional teams deliver on milestones, budgets, and scope.
- Provide oversight for junior project managers, fostering a collaborative and high-performing team environment.
- Champion project timeline excellence, investigator site processes, and risk mitigation, improving efficiency across the project management department.
Global Project Manager II
Celerion, Inc
04.2024 - 04.2025
- In addition to Global Project Manager I responsibilities, served key team member for remote and on-site operational and executive level governance team meetings for strategic accounts.
- Contribute to continuous system and departmental improvements, including implementation of the Clinical Pharmacology model and Project Management Organization (PMO).
Global Project Manager I
Celerion, Inc
02.2023 - 04.2024
- Successfully completed over 10 fast-paced, concurrent Phase I clinical studies in diverse therapeutic areas like Oncology and Neurology. Managed all study logistics at both Celerion's research units and external sites.
- Serve as the primary point of contact for project execution, effectively bridging communication between internal functional groups and external stakeholders.
- Spearhead vendor selection, negotiation, and oversight to ensure successful project execution.
- Coach project coordinators and assist in career development.
Clinical Trials Project Leader I
Duke Clinical Research Institute (DCRI)
02.2022 - 02.2023
- Successfully managed timelines, resources, and budgets for government-sponsored Phase 1b-3b and 510(k) trials within an infectious disease consortium.
- Mentored Associate Project Leaders, fostering their professional development and ensuring project success.
- Served as the primary point of contact for internal and external partners, effectively bridging communication and ensuring collaboration.
Associate Project Leader
Duke Clinical Research Institute (DCRI)
01.2020 - 02.2022
- Partnered with senior Project Leaders to manage complex clinical trials within an infectious disease consortium.
- Developed and managed comprehensive project budgets based on approved scope of work.
- Identified efficiencies and documented processes for future reference, promoting continuous improvement.
- Tracked essential documents, enrollment, and associated site payments.
- Served as the single point of contact for specific functional areas.
Project Assistant
Pharmaceutical Product Development (PPD), Inc
06.2019 - 01.2020
- Maintained a high level of accuracy in all project documentation, ensuring consistency and clarity throughout the lifecycle of projects.
- Reviewed study documents for completeness and adherence to regulatory standards before uploading to the TMF.
- Sustained accurate document tracking within the Clinical Trial Management System (CTMS).
Education
Master of Science - Comparative Biomedical Sciences
University of Georgia
Athens, GABachelor of Science - Animal Science
North Carolina State University
Raleigh, NCSkills
- Effective leader
- Program leadership
- Task delegation
- Strategic planning
- Compliance management
- Stakeholder engagement
Certification
- International Biomedical Regulatory Sciences Certification- University of Georgia
Timeline
Program Director, Global Project Management
Celerion, Inc
04.2025 - Current
Global Project Manager II
Celerion, Inc
04.2024 - 04.2025
Global Project Manager I
Celerion, Inc
02.2023 - 04.2024
Clinical Trials Project Leader I
Duke Clinical Research Institute (DCRI)
02.2022 - 02.2023
Associate Project Leader
Duke Clinical Research Institute (DCRI)
01.2020 - 02.2022
Project Assistant
Pharmaceutical Product Development (PPD), Inc
06.2019 - 01.2020
Bachelor of Science - Animal Science
North Carolina State University
Master of Science - Comparative Biomedical Sciences
University of Georgia
Similar Profiles
Cohen EvansCohen Evans
Clinical Conduct Associate at CelerionClinical Conduct Associate at Celerion
Nolan ReidNolan Reid
Clinical Research Assistant at CelerionClinical Research Assistant at Celerion
Renee LouisRenee Louis
Business Development Director, Bioanalytical at Celerion Clinical TrialsBusiness Development Director, Bioanalytical at Celerion Clinical Trials
CIERA TYSONCIERA TYSON
Quality Assurance Supervisor at MPGQuality Assurance Supervisor at MPG
Juanisha HamiltonJuanisha Hamilton
National Operations Manager at JF PETROLEUM GROUPNational Operations Manager at JF PETROLEUM GROUP