Clinical Trial Operations Specialist

2 days 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. If you have a strong background in clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements, we encourage you to apply.

Key Responsibilities:

  • Manage and coordinate clinical trials from start to finish, ensuring compliance with regulatory requirements and company standards.
  • Develop and maintain strong relationships with CROs, vendors, and internal stakeholders to ensure seamless collaboration and communication.
  • Conduct site initiation visits, monitor clinical trial progress, and identify potential issues for resolution.
  • Collaborate with cross-functional teams to develop and implement clinical trial strategies and protocols.
  • Ensure timely and accurate reporting of clinical trial data and metrics to stakeholders.

Requirements and Qualifications:

  • BS or MS degree in a life science or related field; 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 approximately 25% of the time.

Desired Skills and Experience:

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



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