Odessa Fields

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

years of professional experience

3

years of post-secondary education

3

Languages

Work History

Project Manager

WEP Clinical

Morrisville, NC

01.2025 - Current

Oversees contract negotiation and vendor selection for clinical projects, securing cost-effective solutions without compromising quality or timelines.
Develops strong partnerships with key stakeholders to facilitate smooth handovers during project transitions.
Improves clinical trial efficiency by streamlining project management processes and implementing best practices.
Successfully manages multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
Meets project deadlines without sacrificing build, data quality, patient safety, or regulatory requirements.
Reports regularly to department senior management project budget, progress, and technical problems.
Verifies quality of deliverables and conformance to specifications on regular basis.
Analyzes project performance data to identify areas of improvement.
Enhances team performance with targeted training programs, addressing skill gaps and promoting professional development.
Ensures projects aligned with strategic objectives, working closely with senior management to refine project goals.
Coordinates with cross-functional teams of 20-25 team project members to resolve issues, mitigate risks, and improve quality of deliverables and conformance to specifications to stakeholders.
Oversees multi-million dollar budgets and contracts, collaborates with business development team facilitating leadership progress on resolution utilizing budget financial analysis.
Plans, designs, and schedules phases for large projects.
Meets project deadlines without sacrificing build quality or subject safety.

Senior Clinical Project Coordinator

CTI Clinical Trials & Consulting

Raleigh, NC

04.2023 - 01.2025

Monitored safety reporting procedures, ensuring timely identification and reporting of adverse events according to protocol.
Improved data quality by implementing robust data management processes and adhering to industry best practices.
Ensured compliance with regulatory guidelines through meticulous monitoring of clinical trial documentation.
Mitigated risks associated with clinical trials by conducting thorough risk assessments and establishing contingency plans.
Collaborated closely with investigators in the development of study-specific materials such as informed consent forms.
Streamlined communication between departments for improved project coordination, resulting in timely completion of tasks.
Coordinated eTMF, CTMS, and EDC internal audits for quality assurance purposes, driving continuous improvement within the organization.
Facilitated cross-functional team meetings to provide updates on project status and address any challenges.
Assisted in preparing CTMS and EDC KPIs and clinical study reports and facilitating to stakeholders for semi-regular external project meetings.
Implemented new internal policies and SOP updates, and educated internal team on changes.
Oversaw the logistics of IP, non-IP and biological samples; internal and third party vendor shipping in ambient/temperature control environments.
Reviewed referral information and intake from various referral sources, stakeholder medical officers and principal investigator.
Supervised and managed activities of clinical project team consisting of 15-20 data managers, safety/pharmacovigilance, CRAs, and project specialists.

Clinical Trial Coordinator

PPD Development, A ThermoFisher Scientific Company

Wilmington, NC

07.2021 - 04.2023

1 of 20 Clinical Operation subset supporting Pfizer oncology, metabolic, and cardiology Investigational Drug Trials
Accountable to budget and timeline deliverables for three to five individual studies on current contract; multidisciplinary oversight of Clinical Research Associate, Assistant Research Associates, and central Clinical Trial Coordinator team members; submits biweekly reports and updates findings within CRO CTMS for trial management.
Coordinates and monitors activities of site, vendors, and research monitoring staff to develop risk-mitigation and monitoring contingencies; works with sponsor to obtain feasibility within trial design and relays client expectations to study team.
Operational oversight containing Trial Master File documentation for audit readiness with completeness, timeliness, and quality metrics over 95% throughout duration of study milestones (site selection, site initiation, monitoring, and close-out)
Establishes regular communication with monitoring team and site contacts to support study's SOP; assists with ICON Firecrest vendor requirements for both client-shared and protocol specific trainings; generates reports and mitigates with study specific training plans/sponsor expectations.
Compiles key study quality metrics to help determine appropriate intervention in conjunction with Clinical Trial Manager and Project Management staff; participates in review and discrepancy resolution with client sponsor.
Performs department internal country and site level investigator biannual file reviews as assigned and documents findings in CTMS.
Ensures all study monitoring staff set up and maintain systems to plan and implement trial progress; reviews periodically to track progress throughout study milestones.
Exercises risk analysis reporting to oversee sites with up-to-date knowledge of country-specific ICH-GCP regulatory practices within North America (Canada and US)
Performs strong analytical and problem-solving to develop increased solutions for challenging situations using thorough language to explain complex tasks or issues with study-specific SOP adherence and ICH guidelines; escalates compliance issues to Clinical Trial Manager and Project Management team.
Moderates for QC and completion of Pfizer Trial Master File file uploads; maintains communication with study owner data reviews for completeness, timeliness, and quality metrics to evaluate quality and integrity of site's health.
Manages progress by tracking regulatory IRB submissions, data query resolution, recruitment documentation, case report forms (CRF) and SAE/AE occurrences.

Clinic Coordinator, Pediatric Neuropsychology

Duke Children's Hospital & Health Center

Durham, NC

03.2018 - 07.2021

Facilitated clinical neuropsychological evaluations for Duke Pediatric Neuropsychology program, including pre-processing patient history, patient intake, administration of neuropsychological assessments, and scoring/interpretation.
Developed and updated policies and compliance procedures with statutory, regulatory and local, state and federal guidelines relating to HIPAA, insurance benefits and general liability.
Redesigned workflow processes for patient access and back-office, resulting in reduction of staffing costs by 27%
Assisted staff with implementing testing materials, scoring all protocols and upkeep for electronic and physical patient charts within data storage research standards.
Monitored and inspected staff processes to eliminate hazards posed for residents and staff ensuring continuous compliance with COVID-19 regulations.
Designed leadership development, coaching and team management model, resulting in promotion of employees into increased levels of responsibility.
Set up and secured shared drive with protocol scoring software, program files, final reports and clinic correspondence; backed up original files in accordance with HIPAA standards, hard copies of patient charts, finalized and filed in accordance with hospital standards.
Epic EMR report writing/Charge Router Entry with PB/HB dual charges and clone codes, utilizing proper CPT and HCPCS charge reports and reconciliation based on hospital compliance in conjunction with revenue cycle; clinical and hospital compliance for third party denial reports and resubmission.
Liaised financial regulatory measures, revenue units and encounter close dates in compliance with HIPAA standards.

Bank Teller

Wells Fargo

Chapel Hill, NC

01.2015 - 08.2016

Completed highly accurate, high-volume money counts via both manual and machine-driven approaches.
Supported branch management in achieving operational excellence through adherence to regulatory guidelines and internal procedures.
Provided exceptional customer service, resulting in increased client retention and loyalty.
Managed high-volume transactions during peak hours while maintaining attention to detail, ensuring seamless customer experience.
Answered customer inquiries regarding account balances, transaction history, services charges, and interest rates.
Processed loan payments accurately, contributing to the overall efficiency of branch operations.
Audited fellow teller currency to contribute to dual-control procedures.
Established trust with clients by maintaining confidentiality and protecting sensitive financial information.
Collaborated with team members to achieve monthly sales targets and provide exceptional service to customers.
Contributed to a welcoming branch environment by maintaining a clean and organized workspace for both staff members and customers alike.
Provided cultural input to Spanish-language speakers to help customers communicate with and understand one their banking transactions.
Facilitated customer service-driven metrics over 95% satisfaction on customer activity and survey feedback.
Processed customer transactions promptly, minimizing wait times.
Balanced cash drawers accurately at the end of each shift, minimizing discrepancies in financial records.
Built and strengthened customer relationships by leveraging excellent interpersonal and communication skills.

Assistant Research Associate

Appalachian State University

Boone, NC

06.2014 - 12.2014

Biopsychology experiments involving epigenetic changes in protein expression in rat populations.
Kept track of timing during enriched environment; kept track of settings for validity, maintained video for review and data collection.
Meta-analysis research regarding pediatric TBI patients and role of clinician in treating possible cognitive-linguistic difficulties associated with history of TBI.
Conducted searches of literature related to pediatric traumatic brain injuries; defined parameters of study and focused on pathology/clinical interventions for populations.
Cross-analyzed literature for used occurrence of phrase and word rate in secondary issues related to treating pediatric traumatic brain injuries and treatment in clinical settings using meta-analytics for characteristics not in current practicum.
Wrote/filed grant applications for work sponsored through Office of Student Research; submitted work for consideration for CEC practicing professionals.
Presented findings at Spring Annual 2014 NCSHLA conference in Raleigh, North Carolina for continuing education credit for practicing SLPs; presented findings for OSR annual Research Day.

Education

Bachelor of Science - Rehabilitative Neuroscience (Interdisciplinary)

Appalachian State University, Boone, North Carolina

01.2012 - 12.2014

Summa cum laude
Dean's List 2012-2014
Tau Sigma Honors Society
Secretary - Student American Sign Language Organization, 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

Clinical Data Management

Project Tracking, Planning and Development

Software

CTMS

Oracle

Spotfire

Firecrest

Tangerine

Microsoft Office/Word/PowerPoint

Project Management Software

RedCap Cloud EDC

Medidata RAVE

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