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Local Start-Up Specialist

3 maanden geleden

Schiphol, Nederland Allucent Voltijd

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

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

Requirements

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 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

Benefits

Benefits of working at Allucent include:

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

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 our .

"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." #LI-JC1