clinical trial project manager resume example with 5+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000
Cell:
resumesample@example.com
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Professional Summary
Experienced project manager with over 5 years of experience in clinical trial research. Versatile clinical research professional knowledgeable about managing, coordinating, and monitoring PI-Initiated Phase 1-3 multi-center trials. Highly organized and thorough with good project management and problem-solving abilities.
Skills
In depth experience and knowledge of Phase I-III Oncology PI-Sponsored clinical trials
Interpersonal and communication including proficiency in medical terminology
Excellent attention to detail and commitment to quality
In depth knowledge of GCP, CFR, and ICH Guidelines
Ability to effectively problem solve within cross-functional team
Deep understanding of all aspects of trials, site startup and vendor selection and oversight, study management and site monitoring
Excellent organization and time management
Proficiency in clinical trial software, IT computer literacy, and all Microsoft Office applications
Work History
Clinical Trial Project Manager, 05/2020 to Current Iqvia Holdings Inc – Madison, WI,
Manager of Phase I-III Oncology PI-Sponsored multi-center clinical trials
Participate in site initiation visits and investigator meetings and implementing trials in accordance with study timelines and budgets.
Participate in site selection, qualification, monitoring, and ongoing site/investigator support
Provide oversight and management of investigator and site management issues
Hire, manage, develop and train staff, establish and monitor goals, and conduct performance reviews
Oversee site monitoring report reviews, letters, query resolution, and data requests
Assist with analysis of research data in collaboration with office of data quality and biostatisticians.
Senior Clinical Research Coordinator, 05/2018 to 05/2020 Mayo Clinic – Almena, WI,
Managed and monitored clinical trial sites as per protocol, study-specific data safety monitoring plan, ICH/GCP guidelines, sponsor SOPs and processes.
Managed project activities compromising study start-up activities, site initiation, monitoring, close-out, and database locks.
Assist in protocol, Informed Consent, and CRF design and review
Verify subject safety and site adherence to FDA Regulations, sponsor requirements, and ICH/GCP Guidelines
Mentored office employees on proper procedures, keeping operations consistent and efficient for maximum performance.
Clinical Research Coordinator, 05/2016 to 05/2018 Centura Health – Garden City, KS,
Acted as primary clinical sponsor contact on behalf of PI-Sponsors for investigative sites, outside vendors, and funding sponsors
Established and served as lead central contact between participating clinical sites and sponsor-investigators for multiple clinical trials.
Administered and coordinated logical aspects of clinical trials per CTA, SOPs, and protocols
Created, evaluated, managed, and preserved TMFs, SSFs, and essential documents in compliance with FDA, ICH/GCP regulations, local laws, sponsor and IRB requirements
Education
Bachelor of Arts: Psychology, Expected in 05/2015 to Ithaca College - Ithaca, NY GPA:
Minors: Neuroscience and German
Member of Delta Phi Alpha Academic Honor Society
Pre-Clinical Neuroscience Lab Research Project Leader
Certifications
ICH GCP Certification
CITI HIPAA Research training
Human Subjects Protection Training
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Accomplishments
Co-Authored on seven individual publications within leading journals such as Leukemia, Nature Cell Biology, Cancer, and Blood
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