Job Description

Achieves established project target cycle times for site activations.Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members.May provide support or information for negotiation and finalizing site agreements, budgets and essential documents with study sites in accordance with local/accepted process.Complies with established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.May work directly with site to obtain documents related to site selection.Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.Assists with the preparation of the regulatory compliance review packages, as applicable. This may include working directly with sites.Liaises locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.May develop country or site specific documents.Provides support as needed to help with the coordination with internal functional departments to ensure site startup activities within the site activation critical path are aligned.Ensures that trial status information relating to activities are accurately maintained in the database and is current at all times.