Local Start-up Specialist I/ii

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 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 Local Start-up Specialist I/II is a member of the Study Start-up & Site Intelligence Unit.

**Key Responsibilities**
- 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

**Requirements**:

- Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
- More than 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 Germany
- Attention to detail
- Able to perform well as a team member

**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

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