Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
PPD is currently looking for a Country Approval Specialist to join our team in Belgium, working ideally from our office in Belgium however home based may be considered for an experienced candidate. As a Country Approval Specialist, you will:
· Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
· Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
· Provide project specific local SIA services and coordination of these projects
· May have contact with investigators for submission related activities
· Key-contact at country level for either Ethical or Regulatory submission-related activities
· Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
· May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
· May develop country specific Patient Information Sheet/Informed Consent form documents
· May assist with grant budgets(s) and payment schedules negotiations with sites.
· Support the coordination of feasibility activities, as required, in accordance with agreed timelines
· Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
· Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
· Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided