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Study Start Up Specialist (with Italian)

🇬🇧 United Kingdom | 🇩🇪 Germany | 🇳🇱 Netherlands | 🇫🇷 France | 🇵🇱 Poland | 🇮🇪 Ireland

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Study Start Up Specialist (with Italian)

from 🇬🇧 United Kingdom | 🇩🇪 Germany | 🇳🇱 Netherlands | 🇫🇷 France | 🇵🇱 Poland | 🇮🇪 Ireland

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.

Role and Responsibilities:

1. Site Start-Up Packages
• In cooperation with Project Management create study-specific start-up document package.
• Distribute and follow up with sites to obtain the required executed documents.
• Review content and correctness of returned documents from the sites, in accordance with internal standards.
• In conjunction with Regulatory Affairs, ensure that the correct and complete packages are obtained within the planned timelines. 
 
2. Site Contract and Budget Negotiation
• In co-operation with Contract and Legal, obtain feedback on suggested site and investigator contract language.
• Act as main point of contact for sites to obtain feedback on budget and contract negotiations.
• In conjunction with the Project Manager, provide sites with the suggested study budget and negotiate within pre-approved margins. 
 
3. Site Intelligence Tracking
• Maintain site intelligence tracker with data related to specific requirements for study sites such as start-up timelines, budget, contract negotiation timelines and prerequisites, patient recruitment data etc.
• Provide input for suggested site list during start-up using past experiences with potential study sites. 
 
4. Site Start-Up Planning and Tracking & Project Management Support
• Act as main contact for study sites during start-up.
• Develop and maintain relationships with study sites that will facilitate timely completion of start-up activities. 
• In conjunction with project management and CRAs, plan start-up actions and provide expected SIV dates for individual sites based on previous start-up metrics, as well as regulatory and IRB timelines.
• Track progress of start-up activities in smart sheet and/or CTMS.
• Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
• Provide support to project management with study related activities as 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.
 

Other:

  • 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.

Working Conditions:

  • Home-based.
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by @maxrusakovic