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Study Start Up Specialist (with Italian)

15 hours, 30 minutes ago
France, United Kingdom, Germany, Ireland, Netherlands, Poland
Full-time
Entry Level
Project Coordinator
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 36

Description

  • Support Project Management, Regulatory, and Contract and Legal teams with all site-related start-up activities.
  • Build relationships with study personnel at sites and serve as the main contact during site start-up.
  • Prepare, distribute, and follow up on site start-up documents.
  • Create study-specific start-up document packages in coordination with Project Management.
  • Review returned site documents for completeness and accuracy against internal standards.
  • Coordinate with Regulatory Affairs to obtain complete site start-up packages within planned timelines.
  • Support site contract and budget negotiations, including acting as the point of contact for site feedback.
  • Maintain and update site intelligence trackers with timelines, budget, contract, and recruitment-related data.
  • Plan and track site start-up activities and expected SIV dates using tools such as Smartsheet and/or CTMS.
  • Provide reports, intelligence, and metrics on study start-up progress and support other project management tasks as needed.

Requirements

  • Undergraduate university degree (Bachelor or Honours Bachelor) with minimal training and less than 1 year of related experience.
  • College diploma or degree with 1-3 years of related experience and initial/on-going training.
  • Excellent communication skills.
  • Knowledge of site start-up requirements for clinical studies.
  • Experience working directly with clinical study sites.
  • Very high sense of urgency.
  • English and Italian language skills.
  • Ability to work independently and manage pace and priorities within assigned tasks.
  • Familiarity with regulatory and IRB timeline considerations for site start-up.
  • Experience using smart sheet and/or CTMS is an asset.

Benefits

  • Full-time, permanent employment.
  • Remote home-based working arrangement.
  • Opportunities to work across multiple European locations, including Berlin, Amsterdam, Dublin, London, Paris, and Warsaw.
  • Accommodations for job applicants with disabilities are available upon request.

Interested in this position?

Apply directly on the company website

Apply Now

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