Senior Start Up Associate

Senior SUA

Join our Global Clinical Operations team as a Senior Start Up Associate in Poland.

Senior Start-up Associate is responsible for biomedical research start within a targeted country start-up timelines and client satisfaction, good quality of submission dossiers, and good communication with EC, CA and investigators.

Position is home-based/remote in Poland.

 

Responsibilities:

  • Participate (provide SSU feedback) in the evaluation and selection of qualified investigators and sites for clinical trial conduct
  • Confirm submission strategy and timelines for the initial study submission/approval and amendments submission/approval during the study duration. Keep initially agreed timelines
  • Prepare and submit required clinical trial applications, reports, and other documentation to applicable Authorities (CA/LEC) for initial clinical trial approval and amendments approval, notifications submission during the study duration
  • Prepare submission documents and share with the site for LEC submission
  • Follow up with the site and ensure that submission is done, and approval is received
  • Coordinate communication with applicable Authorities and respond to their queries
  • Prepare clinical trial documents and maintain correspondence and files, store and archive them
  • Track changes in the legal framework regulating all aspects of the conduct of biomedicinal research and update about the changes
  • Support CRA in preparation and negotiation of clinical trial agreements with investigators and institutions
  • Collect/support CRA with the collection of the site essential documents required for IP release approval and compile the IP pack of good quality
  • which corresponds to local regulations to initiate the study in the specific country
  • Collaborate on other projects related to the company activities

Requirements:

  • University degree in Life Science field (Medicine, Pharmacy and etc.)
  • Fluent English language
  • 2 years’ experience in Clinical Research field and at least 1 year experience in CA/LEC submissions in Poland
  • Good knowledge of local biomedical trial regulatory requirements and ICH-GCP
  • Time management and problem-solving skills
  • Ability to work independently and in a team

Benefits of being a part of our team:

  • Professional growth and career opportunities
  • Supportive work environment
  • Additional benefits (bonus system, additional health insurance and etc.)
  • International team
Job Category: Clinical Research
Job Type: Full Time
Job Location: Poland
Job Specification: R2

Apply for this position

Allowed Type(s): .pdf, .doc, .docx