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Clinical Operations Specialist

2 months ago


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

We are seeking a highly skilled and detail-oriented Clinical Operations Specialist to join our team at Syneos Health. As a Clinical Operations Specialist, you will play a critical role in ensuring the smooth execution of clinical trials, from site management to data management.

Key Responsibilities
  • Site Management: Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures, and relevant guidelines.
  • Document Management: Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
  • Communication: Prepare and maintain site manuals, reference tools, and other documents. Maintain, update, and input clinical tracking information into databases.
  • Logistics: Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client. Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.
  • Meetings and Minutes: Assist with coordination of team meetings, attend meetings, and prepare accurate meeting minutes and action items.
  • Case Report Forms and Queries: May handle receipt, tracking, and disposition of Case Report Forms and Queries.
  • Training and Development: Maintain overall awareness in the field of clinical research by completing all necessary and assigned training.
Requirements
  • Education: High School diploma or equivalent.
  • Communication and Interpersonal Skills: Good communication and interpersonal skills.
  • Technology: Ability to embrace new technologies.
  • Language: Fluent in French.
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 to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE