MELISSA L. IWUNZE
Remote Data Entry Specialist
Spring,Texas
Summary
Organized and dependable candidate successful at managing multiple high-volume customer service priorities with a positive attitude. Proven track record of improving customer satisfaction, establishing rapport with clients, and streamlining operations to the success of the organization. Willingness to take on added responsibilities to meet team goals.
Overview
10
10
years of professional experience
Work History
Clinical Trial Manager
DIB Research Group
03.2023 - 09.2023
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Serve as the primary point of contact for sponsors, investigators, and site staff, guiding clincians through the application process and resolving inquiries promptly and accurately.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Managed and organized electronic files and documents in electronic trial manage and delivery systems.
Clinical Operations Manager
Takeda Pharmaceuticals
01.2022 - 12.2022
- Managed clinical trials from inception to completion, ensuring adherence to protocols and timely submission of accurate reports.
- Maintained communication with internal and external stakeholders to ensure the smooth execution of clinical trials.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Serve as the primary point of contact for healthcare professionals (HCPs) and vendors , addressing protocol questions, and other study related inquiries promptly and accurately.
- Assisted in the development and implementation of data entry guidelines, procedures and best practices.
- Entered, updated, and verified data in various clinical management databases and systems with accuracy and efficiency.
Clinical Team Manager
PPD
06.2021 - 09.2021
- Oversaw all aspects of Phase II Nephrology and Renal Diseases clinical trials.
- Led a team of CRAs, driving efficiency and quality in clinical site monitoring for clinical trials.
- Trained CRAs on study protocols and ensured compliance with regulatory requirements.
- Serve as the primary point of contact for CRAs, research sites, and project team members, supporting the clinical team through the project life cycle process and resolving bottlenecks promptly and accurately.
- Reviewed monitoring data and dashboards to assess site performance and implemented corrective actions.
- Collaborating with team members to resolve data discrepancies and address issues promptly.
Interim Clinical Research Manager/Lead Clinical Research Coordinator
Novo Nordisk
04.2013 - 06.2021
- Provided operational expertise and leadership to ensure effective clinical site monitoring across multiple Phase II-III Endocrinology, Nephrology, and Obesity trial activities from site selection through to close-out, ensuring compliance with ICH-GCP and regulatory standards.
- Managed, trained, and mentored a team of 3 CRAs, enhancing their skills in site management, monitoring, and regulatory compliance.
- Led training programs for new and existing CRAs.
- Trained and mentored Senior CRAs, junior CRAs, and new hires, contributing to their professional development and enhancing site management and monitoring skills.
- Serve as the primary point of contact for CRAs, guiding monitors through the inspection readiness and audits and resolving compliance issues promptly and accurately.
- Enhanced clinical trial efficiency by streamlining data collection and analysis processes.
Education
MBA - Business Administration
University of Phoenix
Tempe, AZ 05.2001 -
Master of Science - Health Administration
University of Phoenix
Tempe, AZ 05.2001 -
Skills
- Customer Focus
- Customer Support
- Customer Engagement
- Emotional Intelligence
- Relationship Management
- Data Management
- Data Entry
- Record Management
- Problem Solving/Decision Making
- Excellent Communication
- Organizational Skills
- Analytical Skills
- Adaptability and Flexibility
- Task Prioritization
Online Customer Service | May 2024
- Training to help enhance current customer service skills to create positive interactions with customers and de-escalate conflict, and formulate solutions to customer problems.
Timeline
Clinical Trial Manager
DIB Research Group
03.2023 - 09.2023
Clinical Operations Manager
Takeda Pharmaceuticals
01.2022 - 12.2022
Clinical Team Manager
PPD
06.2021 - 09.2021
Interim Clinical Research Manager/Lead Clinical Research Coordinator
Novo Nordisk
04.2013 - 06.2021
MBA - Business Administration
University of Phoenix
05.2001 -
Master of Science - Health Administration
University of Phoenix
05.2001 -
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