GBI-339: Clinical Trials Project Manager
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.

You will be the primary interface with CRO and will manage communications between monitors and clinical sites and CRO. You will implement and execute clinical programs, including development and administration of site and vendor budgets. Coordinate with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals, and resources. Assist in the writing of protocols, the design of case report forms and other study documents and forms. Work closely with external service vendors to oversee all aspects of clinical trials. Evaluate, tabulate and may prepare written summaries of clinical data. Ensure compliance with protocol, overall clinical objectives and FDA/ICH requirements. Conduct review and source verification of clinical data and ensures timely resolution of data queries. Develop the electronic collection of patient self-reported outcomes (ePro). Maintain contact with clinical investigators and staff. Track all required site documentation.

Qualifications include a BS/MS degree 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.

This is an open contract opportunity for 6+ months, perhaps longer with the potential for continued employment beyond the contract phase.
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