Start-Up Associate II (Germany)

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 Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote)! The SUA 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 and 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.

In this role your key tasks will include:

• 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
• Responsible for collection and first review of Essential Documents
• Provide the Global Essential Document Reviewer with the collected documents for independent review
• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution
• Obtain authorization for the shipment of Investigational Product to the site
• Track relevant information and data in CTMS and/or other tracking tools

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 German and English.
• Attention to detail.
• Able to perform well as a team member.

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral …