Tyrelle Wham
Parker,CO
Summary
Exceptional Clinical Biospecimen Operations Manager adept in clinical trial and project management as well as regulatory compliance. Excelled in enhancing trial efficiency and data integrity, leveraging skills in problem-solving and detail-oriented planning. Demonstrated leadership in mentoring teams and driving cross-functional collaboration for superior clinical trial outcomes.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Clinical Biospecimen Operations Manager
Natera
10.2020 - Current
- Managed the implementation of multiple global and domestic clinical trials including readiness timelines during study startup, conduct management throughout the study, and closure activities while ensuring adherence to regulatory requirements, and ethical guidelines.
- Monitored clinical trial progress by evaluating key performance indicators such as turn-around times, enrollment rates, project risks, testing delays or issues, and study forecasts to determine resourcing requirements for different collaborative functions.
- Prepared, obtained, and maintained clinical documentation and reports required for studies and filed the documentation in organized study files or eTMF.
- Coordinated cross-functional teams including clinical trial services, clinical quality assurance, data management, and product management to ensure alignment and effective implementation of the study.
- Mentored and trained Clinical Biospecimen Operation Managers and monitored progress at various stages throughout the onboarding process.
Project Manager, Advanced Diagnostic Laboratories
National Jewish Health
12.2019 - 10.2020
- Used Smartsheet software to provide project planning, identify and assign tasks, manage project development, identify risks or timeline issues, and determine milestones for over 20 clinical trial studies and research projects.
- Prepared weekly reports for advisory boards and clients regarding the status of projects and trials.
- Defined staff development goals and performance metrics and worked with different departments within the company to collaboratively reach goals and deadlines.
- Created Tableau reports for different studies to pull data from the Laboratory Information System (LIS) and generate cumulative reports with results and demographic information.
- Completed revenue reports for clinical trials and research projects on a monthly basis for 5 different laboratories.
Clinical Trial Department Supervisor
Esoterix Laboratory Services
07.2007 - 05.2018
- Supervised 8 Clinical Laboratory Technicians and 3 Quality Control Technicians in developing over 20 product specific clinical trial assays and providing accurate and timely results and data to pharmaceutical companies and clients.
- Ensured all validation and clinical study data and documentation were complete and accurate, performed quality checks to identify issues, gaps, or discrepancies, and implemented corrective or preventative actions when applicable.
- Worked with the Scientific Directors and Ph.D.'s to resolve resource issues and improve operations to provide exceptional customer service while maintaining regulatory and quality compliance standards.
- Participated in quality improvement and quality assurance processes including onsite evaluations, internal audits, and client audits.
Education
Bachelor of Science - Microbiology
Montana State University - Bozeman
Bozeman, MT12.2003
Certification - ASCP Certified Medical Laboratory Scientist (MLS)
HealthOne Alliance Schoole of Medical Technology
Denver08.2005
Skills
- Clinical trial and project management
- Regulatory compliance
- ICH-GCP guidelines
- Study documentation
- Oral and written communication
- Detail oriented
- Time management
- Multitasking
- Problem solving
- Data collection and analysis
Certification
- ASCP Certified Medical Laboratory Scientist (MLS)
- ACRP - Certified Professional
Timeline
Senior Clinical Biospecimen Operations Manager
Natera
10.2020 - Current
Project Manager, Advanced Diagnostic Laboratories
National Jewish Health
12.2019 - 10.2020
Clinical Trial Department Supervisor
Esoterix Laboratory Services
07.2007 - 05.2018
Bachelor of Science - Microbiology
Montana State University - Bozeman
Certification - ASCP Certified Medical Laboratory Scientist (MLS)
HealthOne Alliance Schoole of Medical Technology
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