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Clinical Trials Coordinator

2 weeks ago

Fremont, California, United States Bayside Solutions Full time
Job Overview
At Bayside Solutions, we are looking for an experienced Associate Director/Director Regulatory Affairs Consultant to join our team. As a key member of our global regulatory function, you will play a critical role in supporting clinical trials and development activities.

Key Responsibilities:
  • Collaborate with internal teams and CROs to prepare and manage regulatory submissions.
  • Develop and maintain knowledge of global regulatory requirements and emerging trends.
  • Provide expertise in clinical trial submissions, particularly in oncology.
  • Support GCP inspection preparation activities and ensure compliance with regulatory standards.

Requirements and Qualifications:
To succeed in this role, you will need a Bachelor's degree in life sciences disciplines and at least 5 years of experience in Regulatory Affairs. A strong background in oncology and clinical trial submissions is highly desirable. You should possess excellent communication and project management skills, with the ability to work independently and collaboratively. Analytical thinking and problem-solving skills are also essential.

Why Join Us:
Bayside Solutions offers a dynamic and supportive work environment, opportunities for growth and development, and a competitive salary range.