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Site Start-Up and Regulatory Specialist II

2 months ago

Montreal, Quebec, Canada Syneos Health Full time
About the Role

We are seeking a highly skilled Site Start-Up and Regulatory Specialist II to join our team at Syneos Health. As a key member of our organization, you will be responsible for ensuring the successful start-up and operation of clinical trial sites.

Key Responsibilities
  • Develop and implement site start-up strategies to ensure timely and efficient site activation.
  • Collaborate with cross-functional teams to ensure regulatory compliance and site quality.
  • Provide guidance and support to site staff on regulatory requirements and site operations.
  • Conduct site visits and audits to ensure compliance with regulatory requirements and site quality standards.
  • Identify and mitigate site risks and issues to ensure successful trial execution.
Requirements
  • Strong knowledge of regulatory requirements and site start-up processes.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and analytical skills.
  • Experience working in a biopharmaceutical or clinical research environment.
About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that make a difference in patients' lives.