Barbara Willis
Frederick,MD
Summary
Dedicated and highly organized professional with over 11 years of experience in operational and regulatory support within the clinical research and healthcare sectors. Proven expertise in managing multiple tasks, supporting senior staff, coordinating schedules, and maintaining sensitive documents in strict compliance with industry regulations. Recognized for delivering exceptional customer service, ensuring regulatory compliance, and maintaining operational efficiency in high-pressure, challenging environments. Proficient in document management, project coordination, and the use of systems such as eTMF, Veeva Clinical Vault (VCV), and Clinical Trial Management System (CTMS) to support the successful execution of clinical trials and regulatory processes.
Overview
12
12
years of professional experience
Work History
Specialist, Global Clinical Solution
AstraZeneca Pharmaceuticals
2024.01 - 2025.03
- Collaborated with cross-functional teams to ensure compliance with clinical and regulatory standards.
- Assisted in developing and implementing process improvements for operational efficiency.
- Conducted data analysis to support decision-making and identify trends in research activities.
- Facilitated training sessions for new team members on company protocols and best practices.
Associate, Global Clinical Solution
AstraZeneca Pharmaceuticals
2021.10 - 2024.01
- Demonstrated respect, friendliness, and willingness to help wherever needed.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Worked flexible hours across night, weekend, and holiday shifts.
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
Document Specialist II
AstraZeneca
2018.05 - 2021.10
- Coordinated document management processes to enhance workflow efficiency across departments.
- Developed and maintained document templates, ensuring consistency and adherence to regulatory standards.
- Implemented electronic filing systems, improving accessibility and reducing retrieval times for critical documents.
- Trained staff on best practices for document creation and management, fostering a culture of accuracy.
Document Specialist I
MedImmune/AstraZeneca Pharmaceuticals
2013.10 - 2018.05
- Developed and maintained document control systems to ensure compliance with industry standards.
- Collaborated with cross-functional teams to streamline documentation processes and reduce turnaround times.
- Reviewed and edited regulatory documents for accuracy, ensuring adherence to company policies and guidelines.
- Trained new staff on document management practices, enhancing team productivity and efficiency.
- Implemented workflow improvements that increased the traceability of critical documents across departments.
- Led initiatives for digital transformation of document storage, improving access and retrieval speed for stakeholders.
- Conducted audits of documentation practices to identify areas for improvement and maintain quality assurance standards.
- Coordinated the preparation of submission-ready materials for regulatory filings, ensuring timely compliance with deadlines.
- Performed regular audits of document repositories, ensuring the accuracy and integrity of all stored information.
- Managed high volumes of documents efficiently, prioritizing tasks according to deadlines and project requirements.
Clinical Documentation Specialist
MedImmune/Aerotek
2013.06 - 2013.10
- Reviewed clinical documentation for accuracy and compliance with regulatory standards.
- Collaborated with cross-functional teams to enhance data integrity and streamline processes.
- Developed training materials for staff on best practices in clinical documentation.
- Audited medical records to identify discrepancies and implement corrective actions.
- Monitored evolving regulations to ensure adherence in clinical documentation efforts.
- Led initiatives to optimize workflows, improving efficiency in documentation processes.
Education
High School Diploma -
Skills
- Customer relations
- Expert problem solving
- Analytical thinking
- Documentation management
- Quality assurance
Timeline
Specialist, Global Clinical Solution
AstraZeneca Pharmaceuticals
2024.01 - 2025.03
Associate, Global Clinical Solution
AstraZeneca Pharmaceuticals
2021.10 - 2024.01
Document Specialist II
AstraZeneca
2018.05 - 2021.10
Document Specialist I
MedImmune/AstraZeneca Pharmaceuticals
2013.10 - 2018.05
Clinical Documentation Specialist
MedImmune/Aerotek
2013.06 - 2013.10
High School Diploma -
In 2007 I received a Founders Award
- Founders award (April 2007) for demonstrating client service (highest award given to employee). Proceeds given to St Jades Children's Hospital
- Exceptional Achievement Award (April 2005) for outstanding support provided to the CDC Regulatory Affairs project.
- Declaration of Appreciation Award (20010 for extraordinary efforts
- Exceptional Achievement Award (1999) for extraordinary efforts Associated with an Food and Drug Inspection for shipment