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. 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.
Site Contract and Budget Negotiation