Clinical Trial Manager

Redwood City  ‐ Onsite
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Keywords

Description

Overview:In this role you will work the company's clinical team to manage clinical operations and execution of global clinical studies for the company's various products. This position will manage CROs, clinical laboratories, and other vendors, including clinical sites; collaborate with clinical development partners, as well as, other internal departments to carryout successful clinical trials.

Roles:
  • Act as primary point of contact to CROs and vendors for assigned clinical studies/programs
  • Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
  • Contribute to the development of clinical protocols, consent forms, monitoring plans, annual regulatory reports, etc
  • Assist in the development, forecasting, monitoring, and reporting of assigned clinical trial budgets
  • May conduct clinical site, CRO, and vendor monitoring visits and co-monitoring visits with CRO staff
  • Facilitate study start up with CROs and clinical sites as necessary
  • Required TRAVEL: approximately 40 %


Requirements:
  • BS and direct relevant experience in global drug development required
  • 5-7 years experience in biotech/pharma clinical operations
  • Experience in managing the execution of complex phase 1-3 global clinical trials
  • Oncology and Immunology clinical trial experience preferred
  • Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management


To find out more about Real please visit www.realstaffing.com
Start date
11/2013
From
Real Staffing
Published at
06.11.2013
Project ID:
622673
Contract type
Freelance
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