Ginnefer Haynes

ginneferhaynes@att.net| Elizabethton, TN 37643 https://www.linkedin.com/in/ginnefer-haynes/

PROFESSIONAL SUMMARY

A highly experienced clinical trials professional with over nine years of experience in project management and operational oversight specializing in clinical research coordination and regulatory compliance. Proven track record in clinical development, regulatory compliance, and document control. Exceptional leadership, communication, and strategic decision-making skills. As a Global Project Manager, I have more than five years of experience managing clinical trial projects, ranging from moderate to high complexity study trials.

EXPERIENCE

Project Manager Oct-2019 – Mar-2025

LabConnect, Remote

Progressively managed complex projects encompassing multi-service and multi-region/country.
Led global cross-functional teams in the successful execution and support of both interventional and non-interventional studies across multiple therapeutic areas.
Oversaw project timelines, budgets, and quality metrics, ensuring alignment with strategic goals and regulatory compliance.
Delivered high-impact communications and presentations to internal and external stakeholders, including sponsors and regulatory bodies.
Mentored and coached global project teams, fostering collaboration, cultural awareness, and high performance.
Utilized systems such as SharePoint, Jira, Veeva, Smartsheet, Salesforce, and Microsoft Office Suite to manage project documentation, reporting, and risk mitigation.
Drove process improvement initiatives and contributed to strategic planning in clinical development and project management.
Managed multimillion-dollar budgets and resource allocations with strong financial acumen and forecasting skills.
Built and maintained strong client relationships, delivering exceptional service and consultation.
Applied advanced negotiation and influencing skills to resolve conflicts and drive project outcomes.
Demonstrated critical thinking and strategic decision-making in managing complex and ambiguous project challenges.

Early Development Services Sep-2015 – Oct-2019

Project Coordinator / Operations Specialist II LabConnect, Johnson City, TN

Provided digital product management for clinical support systems to ensure seamless integration and optimal functionality across platforms.
Built and validated digital requisition templates within clinical systems (e.g., LIMS), ensuring accurate mapping of test codes, visit schedules, and sample logistics.
Collaborated with cross-functional teams (e.g., data management, IT, clinical operations) to define and document digital requisition requirements aligned with protocol specifications.
Designed and implemented digital requisition mapping workflows to streamline clinical trial supply chain and laboratory data integration processes.
Conducted UAT (User Acceptance Testing) and troubleshooting for digital requisition builds, ensuring functionality and alignment with study protocols.
Managed specialty sample collection and tracking processes to maintain high accuracy and operational efficiency.
Oversaw clinical laboratory operations and report turnaround times to ensure timely and precise delivery of results.
Monitored departmental metrics to support data-driven decisions and continuous process improvement.
Conducted quality control checks on samples and shipment manifests to ensure compliance with regulatory and quality standards.
Delivered operational oversight and departmental training to enhance team performance and regulatory adherence.

Quality Administrator Jul-2015 – Sep-2015

LabConnect, Johnson City, TN

Maintained comprehensive documentation of laboratory accreditations, certifications, licenses, and medical director CVs to ensure audit readiness and compliance.
Facilitated and participated in audit reviews, contributing to successful outcomes and adherence to regulatory requirements.
Performed document control activities, including version tracking, distribution, and compliance with internal SOPs.
Identified and captured incidents to support quality assurance.
Imported and maintained data in Excel spreadsheets and standardized forms, ensuring accuracy and consistency.
Managed the incident reporting system to ensure accurate documentation and timely resolution of operational issues.
Assisted with CAPA processes to support continuous improvement and maintain alignment with quality assurance protocols.
Maintained and updated employee training records, ensuring compliance with training requirements and audit readiness.

MAP/PAP Specialist Dec-2012 – Dec-2014

Medication Assistance Program / Patient Assistance Program

Mountain States Health Alliance (MSHA) Contracted Patient Engagement Advisors (PEA), Johnson City, TN

Aided in the creation and enhancement of medication and patient assistance programs by coordinating with pharmaceutical companies and hospital departments to improve patient access to care.
Managed patient assistance programs across multiple hospitals, ensuring consistent support and medication availability for eligible patients.
Facilitated communication between clinical staff and shipping/receiving departments to guarantee timely delivery of critical medications.
Saved the organization over $1 million in reimbursements by optimizing medication and patient assistance program utilization.

SKILLS

EDUCATION

Bachelor of Science (BS), Healthcare Administration/Management Dec-2016

King University

CERTIFICATIONS

GCP, NIDA / NIH

IATA “Dangerous Goods Shipping”, MAYO CLINIC Mayo Medical Laboratories

AWARDS/RECOGNITIONS/VOLUNTEER WORK

Recognition of Budgetary Oversight Success, Aided in the settlement of unpaid invoices, resulting in the recompense of hundreds of thousands of dollars in backdated invoices.
Recognition of Successful Clinical Trial Management, Leading clinical trials to FDA approvals.
Recognized and Requested Directly for Integrity Restoration, Effectively managed rescue studies to restore data integrity, achieving and maintaining credibility.
Recognition for Securing Medication Reimbursements, saving the corporation over $1M.
Recognition for Enhanced Study Compliance, Developed training modules used by 20+ investigators, that increased and improved study compliance.