Clinical Project Manager Metabolex
THIS JOB HAS EXPIRED Department: Clinical Development
Salary: Commensurate With Experience
Benefits: No Benefits
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CLINICAL PROJECT MANAGER (Contract Hire)
Metabolex Inc. is a privately-held biotechnology company focused on the discovery and development of novel therapeutics for the treatment of metabolic diseases. We have a great opportunity in Hayward, CA for a motivated individual to join our clinical development group as a contract employee. This individual will oversee the conduct of a Phase 2 clinical study on gout.
The Clinical Project Manager will oversee the conduct of clinical studies and ensures that studies are completed on time within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
Primary interface with CRO
Manages communications between monitors and clinical sites and CRO
Implements and executes clinical programs, including development and administration of site and vendor budgets
Coordinates with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals, and resources
Assists in the writing of protocols, the design of case report forms and other study documents and forms
Works closely with external service vendors to oversee all aspects of clinical trials
Evaluates, tabulates and may prepare written summaries of clinical data
Ensures compliance with protocol, overall clinical objectives and FDA/ICH requirements
Conducts review and source verification of clinical data and ensures timely resolution of data queries
Develops the electronic collection of patient self-reported outcomes (ePro)
Maintains contact with clinical investigators and staff
Tracks all required site documentation.
The position requires a BS, (MS preferred) or equivalent in life sciences, or related technical degree with 8+ years of experience. Experience managing multi-site trials, CROs and other vendors required. Thorough knowledge of GCP/ICH requirements needed.
||3876 Bay Center Place |
Hayward, CA 94545
THIS JOB HAS EXPIRED