Local Start-Up Specialist I/II

at  Allucent

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS may also perform site contract and budget negotiations and execution of negotiated contracts.
The Local Start-up Specialist I/II is a member of the Study Start-up & Site Intelligence Unit.

• 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
• 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
• 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. Ensure these changes and updates are communicated and circulated as appropriate
• Assist in adapting country SIS/ISF to site-specific requirements
• Provide country specific requirements to GSCM impacting site contracts’ process
• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
• Negotiate within client approved contract and budget templates and negotiation parameters
• Communicate with sites and internal personnel regarding the status of contracts and contract related documents
• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable
• Provide the final/draft CTA and site budget for submission, where required
• Obtain site signature as well as Sponsor/Allucent signature, as applicable
• Keep up to date with applicable local regulations impacting clinical trial contracts
• Assist in preparing the site-specific Essential Document Package and sending to sites