Start-Up Associate II (Germany)

Allucent; München; Hybrid; EUR 50.000 - 70.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits per location

Competitive salaries per location

Study/training budget

Flexible working hours

Buddy Program

Internal career progression

Employee referral program

Spot Bonus Award Program

Loyalty Award Program

Zusammenfassung

Allucent is seeking a Start-Up Associate II to join the A-team in a hybrid/remote setup. The role coordinates local start-up activities, handles regulatory submissions with RA/IEC/IRB, and acts as a primary communication link with authorities and sites through the initial phase of a clinical study.

Candidate should have a life science degree and 2+ years in regulatory affairs, with fluent German and English, strong attention to detail, and team-oriented collaboration.

Qualifikationen

• Life science degree or equivalent qualification.
• 2+ years regulatory affairs experience in pharma/biotech.
• Thorough knowledge of local submission requirements.
• Fluent in German and English.
• Strong communication and teamwork skills.

Aufgaben

• Coordinate and perform local site start-up activities and regulatory submissions.
• Maintain documentation in CTMS/eTMF and interact with RA/IEC/IRB.
• Prepare CTAs, budgets, and site contracts; obtain signatures.
• Communicate regulatory updates to study teams.
• Support country SIS/ISF adaptations.

Kenntnisse

Regulatory affairs experience

Drug development knowledge

Fluent in German & English

Attention to detail

Team player

Ausbildung

Life Science degree or equivalent

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 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 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 German and English
• 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)
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• 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 in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.