Summary: Seeking a Clinical Manager with expertise in clinical trials administration and nuclear medicine diagnostics for overseeing study protocols and vendor management.

Requirements:

BS or MS Degree in scientific or healthcare field. 5+ years of relevant experience with 2+ years in Clinical Trials Administration. Experience in Nuclear Medicine diagnostic and therapeutic clinical trials. Knowledge of FDA regulations, ICH Guidelines, cGCP, and pharmaceutical GXP.

Preferred Skills:

Experience with CRO/vendor management and budget monitoring. Knowledge of data management/biostatistics processes and pharmacovigilance.

Responsibilities:

Review study-related documents like protocols, eCRF design, laboratory manuals, etc. Participate in defining and executing the Clinical Study Management Plan. Collaborate with Key Opinion Leaders to integrate feedback into protocols. Contribute to regulatory documents like Investigator's Brochures, IND/NDA submissions. Monitor study progress ensuring compliance with regulations and guidelines. Revise scope of service agreements, budgets, plans with CROs. Perform financial management including review of invoices and site payments.

Pay Details: $115,000.00 to $120,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance