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Clinical Trial Operations Specialist

2 months ago

Reston, Virginia, United States Bayside Solutions Full time
Clinical Trial Manager

Job Type: W2 Contract-to-Hire

Salary Range: $156,000 - $176,800 per year

Location: Redwood City, CA - Hybrid or Remote PST

Job Summary:

This is an exciting opportunity for an experienced Clinical Operations Professional to join our team at Bayside Solutions. As a Clinical Trial Manager, you will be responsible for overseeing Contract Research Organizations (CROs) and ensuring the successful execution of our clinical studies. We are looking for someone with technical expertise in managing Phase I-III clinical trials within an industry setting and a solid understanding of clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements.

Key Responsibilities:

  • Manage CROs and vendors to ensure timely and successful execution of clinical studies
  • Develop and implement clinical trial strategies to meet business objectives
  • Collaborate with cross-functional teams to ensure seamless study execution
  • Ensure compliance with FDA regulations, ICH Guidelines, and GCPs
  • Provide leadership and guidance to junior team members

Requirements and Qualifications:

  • BS or MS degree; 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably in oncology drug development
  • Hands-on experience in running early-stage clinical trials within an industry environment
  • Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Experience in the selection of CROs and vendors and management of external resources
  • Able to travel (~25%)

Desired Skills and Experience:

Clinical trial, Oncology, drug development, ICH Guidelines, FDA Regulations, GCP, CRO, vendor management, travel

Bayside Solutions, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.