Regulatory and Start Up Specialist - Poland

Job description

Regulatory and Start Up Specialist Poland - Homebased: Fixed Term Contract Job Overview: Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Home Based opportunity that requires Polish language fluency. Essential Functions: - Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. - Distribute completed documents to sites and internal project team members. - Prepare site regulatory documents, reviewing for completeness and accuracy. - Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific inf...