Highly accomplished and results-driven Global Clinical Trial Manager with over 10 years experience in successfully managing complex clinical trials across multiple countries and therapeutic areas. Demonstrated expertise in leading cross-functional teams, ensuring adherence to regulatory guidelines, and delivering projects. Proven ability to mitigate risks, optimize processes, and drive operational excellence to achieve study objectives.
Hi, I’m
Prentice Davis JR, DC
Atlanta,GA
Summary
Overview
11
years of professional experience
Work History
ICON Clinical ResearchRaleigh, NC
Global Clinical Trial Manager(Contracted to Amgen)
06.2022 - Current
Job overview
- Lead in the implementation of EU- CTR transition for ongoing clinical trial
- Track Project Deliverables and timelines
- Kept patient care protocols and clinical trial operations in compliance.
- Ensure feasibility and country and site selection process are within timelines.
- Gathered and reviewed study data.
- Monitored subject enrollment and tracked dropout details.
- Successfully served as the Global Clinical lead for a Phase II Oncology and Phase III and IV Neurology Trials
- Oversaw quality and scientific integrity of Clinical Operations for studies on a global level
- Track and report activities and payments to collaborators and vendors
- Reconciled study budgets
- Vendor management
- Ensured that effective study risk management was in place across all areas of the study
- Development and leadership of the cross- functional Clinical Study Team
- Lead the implementation of global drug supply plan
- Accountability for study TMF completeness and quality and inspection readiness
ICON Clinical ResearchRaleigh, NC
Regional Clinical Trial Manager( Fsp Amgen)
09.2021 - 06.2022
Job overview
- Lead and managed the conduct of An Amgen priority clinical trial in accordance with ICH-GCP and applicable local regulations
- Worked with Global Trial Manager to develop the trial plan including timelines, goals and objectives
- Site Selection and evaluation
- Ensured effective study risk management
- Collaborated with cross-functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables
- Collaborate, communicate and lead local affiliate colleagues to ensure a robust understanding of study specific requirements and milestone delivery
- Provided trial leadership and support too the study team
- Served as the key point of communication between local and global teams
- Responsible for study TMF completeness, quality and inspection readiness
ICON Clinical ResearchRaleigh, NC
Senior Clinical Research Associate (Fsp Janssen)
04.2017 - 08.2021
Job overview
- Checked electronic data capturing systems for integrity and compliance.
- Conducted independent research to assimilate results for technical reports and publications.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Identified potential threats to properly manage project risks.
- Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
- Tracked study-specific trial management tools and systems.
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
- Delegated tasks to teams developing project schedules, resource requirements and timelines.
- Performed pre-study, closeout and interim visits to check on study activities.
- Communicated research and analytical findings to research team.
- Managed study site with strict adherence to data security measures.
- Evaluated proof of eligibility and consent for participants.
- Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
INC ResearchRaleigh, NC
Clinical Research Associate
06.2016 - 04.2017
Job overview
- Checked electronic data capturing systems for integrity and compliance.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Developed and led department training for site investigator staff.
- Conducted all activities according to defined project-specific quality and performance standards.
- Collected and authenticated data collection forms to read and interpret complex clinical protocols.
- Maintained strict confidentiality to keep personal information and collected data private.
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Supported investigator selection and qualification process by offering professional input.
- Evaluated proof of eligibility and consent for participants.
- Reported to project manager for issues related to overall study status.
Worldwide Clinical TrialsTriangle Park, NC
Clinical Research Associate
12.2012 - 05.2015
Job overview
- Gathered and reviewed study data.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Monitored subject enrollment and tracked dropout details.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Displayed strong telephone etiquette, effectively handling difficult calls.
- Exceeded customer satisfaction by finding creative solutions to problems.
- Kept patient care protocols and clinical trial operations in compliance.
- Checked electronic data capturing systems for integrity and compliance.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Collected and authenticated data collection forms to read and interpret complex clinical protocols.
- Monitored site activities and sent follow-up letters to participants.
- Communicated with vendors to deliver appropriate clinical supplies to key areas and meet ongoing operational demands.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Achieved project-specific quality and performance standards and provided documentation and communication.
Education
Life UniversityMarietta, GA
Doctor of Chiropractic from Chiropractic
12.2012
University Overview
Skills
- Clinical Trial Management
- Project Management
- Leadership and Team Management
- Communication and Interpersonal skills
- Cultural competence
- Regulatory Compliance
- Problem Solving and Decision Making
- Risk Management
- Data Management and Analysis
- Continuous Learning and Adaptability
Timeline
Global Clinical Trial Manager(Contracted to Amgen)
ICON Clinical Research
06.2022 - Current
Regional Clinical Trial Manager( Fsp Amgen)
ICON Clinical Research
09.2021 - 06.2022
Senior Clinical Research Associate (Fsp Janssen)
ICON Clinical Research
04.2017 - 08.2021
Clinical Research Associate
INC Research
06.2016 - 04.2017
Clinical Research Associate
Worldwide Clinical Trials
12.2012 - 05.2015
Life University
Doctor of Chiropractic from Chiropractic
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