Odessa Fields
Durham
Summary
Clinical project manager with over five years of clinical trial management. Comfortability leading global multi-site trials, resulting in FDA Breakthrough status award. Strong metrics, KPI record, and audit-readiness. Detail-oriented, strong organizational skills, and comfortability relaying needs across functional disciplines as a leader.
Overview
12
12
years of professional experience
Work History
Project Manager
WEP Clinical
01.2025 - Current
- Secured cost-effective vendor contracts for clinical projects without compromising quality.
- Led cross-functional teams to deliver projects on time and within budget.
- Developed project plans, timelines, and resource allocation strategies.
- Developed partnerships with stakeholders to ensure smooth project transitions.
- Streamlined project management processes, enhancing clinical trial efficiency and best practices.
- Successfully prioritized tasks to manage multiple projects aligning with organizational goals.
- Reported project budget and progress to senior management regularly, addressing technical issues.
- Verified deliverables for quality and compliance with specifications on a regular basis.
- Implemented process improvements that enhanced operational efficiency by 30%.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
Senior Clinical Project Coordinator
CTI Clinical Trials & Consulting
04.2023 - 01.2025
- Managed MindMed Phase 2b MM120 GAD clinical trial, awarded Breakthrough status by the Federal Drug Administration.
- Coordinated cross-functional teams to ensure timely project execution and compliance with regulatory standards.
- Ensured timely reporting of adverse events by monitoring safety procedures.
- Developed and maintained project timelines, identifying risks and implementing mitigation strategies.
- Enhanced data quality through effective management processes and industry best practices.
- Maintained compliance with regulatory guidelines by monitoring clinical trial documentation.
- Reduced clinical trial risks through comprehensive risk assessments and contingency planning.
- Collaborated with investigators to develop essential study-specific materials.
- Streamlined interdepartmental communication, resulting in improved project coordination and completion times.
- Coordinated internal audits for eTMF, CTMS, and EDC to ensure quality assurance.
Clinical Trial Coordinator
PPD Development, A ThermoFisher Scientific Company
07.2021 - 04.2023
- Supported Pfizer oncology, metabolic, and cardiology drug trials as part of 20-member team.
- Managed budgets and timelines for up to five individual studies per contract.
- Coordinated site and vendor activities to mitigate risk and ensure compliance.
- Maintained Trial Master File for audit readiness with over 95% quality metrics.
- Established communication with monitoring teams to ensure adherence to study SOPs.
- Conducted biannual file reviews and documented findings in CTMS for compliance.
Clinic Coordinator, Pediatric Neuropsychology
Duke Children's Hospital & Health Center
03.2018 - 07.2021
- Facilitated neuropsychological evaluations, enhancing patient care processes and outcomes.
- Developed policies ensuring compliance with HIPAA and regulatory guidelines.
- Redesigned workflows, achieving a 27% reduction in staffing costs.
- Assisted staff in implementing testing materials and maintaining patient data accuracy.
- Monitored procedures to ensure staff and resident safety during COVID-19 compliance.
- Designed leadership development programs, promoting employee advancement and responsibility.
Bank Teller
Wells Fargo
01.2015 - 08.2016
- Achieved operational excellence through strict adherence to regulations and procedures.
- Enhanced customer loyalty by consistently providing exceptional service and support.
- Managed peak transaction volumes while ensuring detailed accuracy and customer satisfaction.
- Resolved customer inquiries regarding account details and service charges efficiently.
- Processed loan payments accurately, improving overall branch operational efficiency.
- Maintained confidentiality, fostering trust with clients regarding their financial information.
- Processed customer transactions efficiently, ensuring accuracy and adherence to banking protocols.
- Assisted customers with account inquiries, providing clear information and resolving issues promptly.
- Maintained cash drawer integrity through regular audits and reconciliations, minimizing discrepancies by 95%.
- Monitored compliance with regulatory guidelines, ensuring all transactions adhered to institutional policies.
Assistant Research Associate
Appalachian State University
06.2014 - 12.2014
- Facilitated significant findings in biopsychology through epigenetic protein expression experiments.
- Analyzed data using statistical software to derive meaningful insights with metrics of >0.05 statistical anomalies.
- Monitored timing and settings during experiments to ensure data collection validity.
- Conducted meta-analysis on pediatric TBI patients and clinician cognitive-linguistic interventions.
- Researched literature on pediatric TBIs, defining study parameters and clinical interventions.
- Cross-analyzed literature for word occurrences in pediatric TBI treatment settings.
- Authored and submitted grant applications to Office of Student Research for funding.
- Presented research findings at NCSHLA conference and OSR annual Research Day.
Education
Bachelor of Science - Rehabilitative Neuroscience (Interdisciplinary)
Appalachian State University
Boone, North Carolina12.2014
Skills
Leadership skills
Independent starter
Strong cooperative team player
CTMS/EDC Training
Audit preparedness
Pharmacovigilence/Safety Reporting
ICH/GxP Standards
Clinical Monitoring and Site Reporting
Languages
English
Excellent
Spanish
Very Good
French
Good
Timeline
Project Manager
WEP Clinical
01.2025 - Current
Senior Clinical Project Coordinator
CTI Clinical Trials & Consulting
04.2023 - 01.2025
Clinical Trial Coordinator
PPD Development, A ThermoFisher Scientific Company
07.2021 - 04.2023
Clinic Coordinator, Pediatric Neuropsychology
Duke Children's Hospital & Health Center
03.2018 - 07.2021
Bank Teller
Wells Fargo
01.2015 - 08.2016
Assistant Research Associate
Appalachian State University
06.2014 - 12.2014
Bachelor of Science - Rehabilitative Neuroscience (Interdisciplinary)
Appalachian State University
Software
- CTMS
- Oracle
- Spotfire
- Firecrest
- Tangerine
- Microsoft Office/Word/PowerPoint
- Project Management Software
- RedCap Cloud EDC
- Medidata RAVE