Local Start-Up Specialist II (Germany)

Allucent; Köln; Hybrid; EUR 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits per location

Competitive salaries per location

Flexible working hours

Remote/hybrid working depending on loc

Leadership and mentoring opportunities

Internal growth opportunities

Zusammenfassung

Allucent is seeking a Local Start Up Specialist II to join our A-team on a hybrid/remote basis. The LSUS coordinates local site start-up activities, manages regulatory submissions, and serves as the main contact with RA/IEC/IRB and investigators through the initial phase of a clinical study.

This role requires a Life Science degree, 2+ years regulatory affairs experience, and strong English/Spanish communication; offers flexible hours and opportunities for growth.

Qualifikationen

• Life Science degree or equivalent qualification or certification in a related allied health profession
• 2+ years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
• Knowledge of country/region competent authority submission and reporting requirements and guidelines
• Strong English and Spanish communication skills

Aufgaben

• Coordinate local start-up activities and regulatory submissions with RA/IEC/IRB
• Prepare and maintain essential regulatory documents and CTMS entries
• Interact with regulatory authorities and IEC/IRB
• Prepare and compile answers to questions from regulatory agencies and IEC/IRB
• Track regulatory milestones and updates in CTMS or tracking tools

Kenntnisse

English and Spanish

Attention to detail

Team player

Ausbildung

Life Science degree or equivalent qualification

Jobbeschreibung

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 II (LSUS) to join our A-team (hybrid*/remote)! The 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 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 roleyour 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

To be successful you will possess:

• 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 Spanish
• Attention to detail
• Able to perform well as a team member

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of ourglobal offices.

The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.