.These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You'll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you'll help make a positive difference in patients' lives.We are looking for a highly skilled and experienced **Local Start Up Specialist **with essential documentation collection, review and various submission expertise to join our team**.**The Local Start-Up Specialist coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence Unit. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.The LSUS will be responsible for the following tasks:**General activities**- Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)- Ensure planned dates are reliable and up to date in CTMS departments/study teams- File documents in the (e)TMF for which they are the document owner- Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner**RA submission/approval activities, if applicable**- Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level- Provide relevant documents in compliance with local regulation- Support review of technical, pre-clinical and clinical reports for regulatory submissions- Interact with regulatory authorities- Prepare and compile answers for questions raised by the regulatory agencies and submit the answers- Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate- Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed**IEC/IRB submission/approval activities**- Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level- Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation- Interact with IEC/IRB- Prepare and compile answers for questions raised by the IEC/IRB and submit the answers- Regularly check for updates on regulations, guidelines, and procedures