Study Start Up Specialist (with Italian)
Remote · London, England, United Kingdom or Amsterdam, North Holland, The Netherlands
Job Summary
Support project management, regulatory, and contract and legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare, distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and tools. Provide reports on intelligence and metrics related to study start-up activities. Responsibilities include creating study-specific start-up document packages, distributing and obtaining executed documents, coordinating with Regulatory Affairs to ensure complete packages within timelines, negotiating site contracts and budgets with Contract and Legal, maintaining site intelligence trackers and providing input for site lists, and planning start-up actions with project management to meet timelines and regulatory requirements. Working Conditions: Home-based; Locations: Berlin, Amsterdam, Dublin, London, Paris, Warsaw.
Required Qualifications
- Undergraduate university degree (Bachelor or Honors Bachelor) and Minimal Training (brief orientation or introductory training); less than 1 years' related experience
- Or College Diploma/Degree and 1-3 years' related experience with initial and On-going training
- Excellent communication skills
- Knowledge of start-up requirements for clinical sites
- Experience in working directly with clinical study sites through previous involvement in studies
- Very high sense of urgency
- Some financial responsibility (handling of small cash floats, minimal spending limits, can provide input during department budget creation)
- Sets personal pace and content (significant scope for setting pace and action order within the context of tasks to complete)
- Large number of regular contacts (team/unit members/vendors/clients, occasionally difficult, requiring patience and tact)
- English and Italian language skills
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