Remote Local Start-Up Specialist II

Summary

The job is for a Local Start Up Specialist II (LSUS) at Allucent™, a company that helps small-medium biopharmaceutical companies navigate clinical trials. The LSUS will coordinate and perform local site start-up activities, including document collection, regulatory authority submission/approval, site contract and budget negotiations, and more.

Requirements

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
• 2+ years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in English and either Dutch or French
• Attention to detail
• Able to perform well as a team member

Responsibilities

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities
• 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

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for fully remote working or hybrid Working Model
• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal Employee Referral Program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms