Clinical Trial Manager
ICONMA, LLC
Our Client, a Research, Care and Health Financing company, is looking for a Clinical Trial Manager for their San Bruno, CA / Hybrid location. Responsibilities:
+ Oversee/collaborate all operational aspects for the implementation of clinical study activities from study start-up through database lock, ensuring relevant practices (e.g. Good Clinical Practices, Good Pharmacoepidemiology Practices, Common Rule) and relevant Standard Operating Procedures (SOPs) are met.
+ Work closely with cross-functional teams on clinical study delivery for Client sponsored and externally Sponsored research projects.
+ Drive development of study-related materials, such as Monitoring Plans, Trial Master File Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, informed consent, site instructions/training, and other aspects of study operations.
+ Review monitoring/data reports, protocol deviations to ensure reliable quality data is delivered; coordinate/manage Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
+ Communicate directly with study site staff and investigators; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.
Requirements:
+ BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
+ Experience in study project management and prior management of contracted resources/CROs.
+ 5+ years of clinical study management experience in registries, observational research, RWD/E, or device research as a clinical study lead/project manager.
+ Experience managing decentralized clinical studies (DCTs) and deploying DCT solutions.
+ Experience with RWD/E generation research (e.g., registries, observational research, RWD collection).
+ Experience in medical device deployment and study management
+ Experience in site monitoring, clinical quality compliance and international study management.
+ In depth knowledge of Good Clinical Practices, Good Pharmacoepidemiology Practice and current knowledge of FDA regulations for human subjects research, and strong understanding of clinical study systems (TMF, EDC, etc).
Why Should You Apply?
+ Health Benefits
+ Referral Program
+ Excellent growth and advancement opportunities
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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