Rhonda Daniel
Glen Allen,Virginia
Summary
Team-oriented clinical trail manager with proven leadership and motivational skills successful in helping group members achieve business goals. Respectful and clear communicator focused on enhancing teamwork and collaboratively addressing challenges with logical approaches. Skilled in building relationships and enhancing employee satisfaction to drive work performance.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Group Leader
PPD, Part of Thermo Fisher Scientific
04.2023 - Current
- Spearhead Phase I-IV clinical vaccine trials, ensuring seamless execution and adherence to strict timelines
- Author Clinical Monitoring Plans (CMP) and Standard Operating Procedures (SOPs), continually refining study protocols and methodologies
- Support the timely completion of regulated and non-regulated studies, contributing to the lab's reputation for reliability
- Proactively identify and resolve potential clinical study issues by fostering collaboration across teams and addressing concerns preemptively
- Promote cross-team collaboration for effective study planning and execution, ensuring prompt delivery and adept handling of atypical events
- Direct laboratory staff, optimizing resource allocation and steering projects towards successful outcomes within defined timelines
- Enhance daily operations, guaranteeing high-quality results and adherence to project schedules
- Address QA and regulatory audit findings, maintaining uncompromising compliance standards
- Enhance daily operations, ensuring high-quality outcomes and adherence to project schedules
- Maintain exceptional client satisfaction levels through diligent responsiveness and customer service excellence
- Utilize financial and quality management tools to monitor project progress and quality, ensuring efficient achievement of objectives
- Facilitate the introduction of new assay programs and qualified/validation of instrumentation, bolstering laboratory capabilities
- Implement and monitor Corrective and Preventive Actions (CAPAs), elevating quality standards and addressing root causes of issues
- Nurture the career growth of direct reports through mentorship, fostering internal mobility and professional development opportunities.
Associate Group Leader
PPD, Part of Thermo Fisher Scientific
11.2019 - 03.2023
- Provided line-level management coordination of resources and work schedules for laboratory activities
- Oversaw daily operations and assisted in preparation and implementation of company policies and quality systems
- Ensured that projects are completed in a timely manner so that company revenues are met, and clients are satisfied with the quality and turnaround time of work being performed
- Ensured that laboratory staff continued to be developed to keep pace with department goals and growth.
Senior Scientist
02.2019 - 11.2019
- Cultured, differentiated, and harvested HL-60 cells in a high-throughput GLP-compliant BSL-2 laboratory to be used in cell based assays
- Determined quality of differentiation and viability of cells using flow cytometry
- Scheduling Coordinator: scheduled department analysts to perform clinical lab procedures, multiple R&D projects, and overtime work
- Training coordinator: trained new analysts from onboarding through qualification on established SOPs, oversaw a group of trainers, and coordinated qualification runs performed by the assay team
- Environmental Monitoring Backup Coordinator: contamination response/ prevention and identification of contaminants
- Bench sheet design and creation using FormDocs and FormDocs Designer
- Assisted in review and compilation of data of data for several FDA approved clinical projects
- Creation and revision of SOPs pertaining to cell culture and cell-based assays.
Scientist
06.2018 - 01.2019
- Cultured, differentiated, and harvested HL-60 cells in a high-throughput GLP-compliant BSL-2 laboratory to be used in cell based assays
- Determined quality of differentiation and viability of cells using flow cytometry
- Environmental Monitoring Backup Coordinator: contamination response/ prevention and identification of contaminants.
Associate Scientist
10.2016 - 05.2018
- Culture, differentiate, and harvest HL-60 cells in a high-throughput GLP-compliant BSL-2 laboratory to be used in cell based assays.
Education
Masters of Science - Biochemistry
Virginia Commonwealth University
Richmond, VA05.2015
Bachelor of Science - Forensic Science
Virginia Commonwealth University
Richmond, VA12.2012
Skills
Verbal and written communication
Management of Junior Staff
MS Office (Including Project)
SOP Authoring
LIMS
Phase II-IV Vaccine Trial Management
Quality Monitoring Systems (QMS ie Veeva Vault, Trackwise)
Corrective and Preventive Action (CAPA)
GLP and GCP Compliance
Publications
- Dysregulation of microRNAs in Blood as Biomarkers for Diagnosing Prostate Cancer, R. Daniel, Q. Wu, G. Clark, Z. E Zehner, 08/05/2015
- MiR-9 Acts as an OncomiR in Prostate Cancer through Multiple Pathways That Drive Tumour Progression and Metastasis, S. J. Seashols-Williams, W. Budd, G. C. Clark, R. Daniel, Q. Wu, E. Dragoescu, Z. E. Zehner, 07/22/2016
Certification
PMP Certification in progress
Languages
English
Native or Bilingual
Arabic
Native or Bilingual
Timeline
Group Leader
PPD, Part of Thermo Fisher Scientific
04.2023 - Current
Associate Group Leader
PPD, Part of Thermo Fisher Scientific
11.2019 - 03.2023
Senior Scientist
02.2019 - 11.2019
Scientist
06.2018 - 01.2019
Associate Scientist
10.2016 - 05.2018
Masters of Science - Biochemistry
Virginia Commonwealth University
Bachelor of Science - Forensic Science
Virginia Commonwealth University
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