Remote Local Start-Up Specialist
closedAllucent
πRemote - Spain
Job highlights
Summary
The job is for a Local Start Up Specialist I/II (LSUS) at Allucentβ’. The role involves coordinating local site start-up activities, including document collection, Regulatory Authority submission/approval, and acting as a main line of communication to RA/IEC/IRB. The position is hybrid/remote and requires a Life Science degree or equivalent qualification, 2+ years of experience in regulatory affairs, good communications skills in English and Spanish, and knowledge of country competent authority requirements.
Requirements
- Life Science degree or equivalent qualification from an appropriate accredited institution
- More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
- Thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines
- 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
Responsibilities
- Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities
- 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 contractsβ 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
Benefits
- 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
This job is filled or no longer available
Similar Remote Jobs
- πAustralia
- πAustralia
- πUnited States
- π°$106k-$159kπUnited States
- πTaiwan (country)
- πTaiwan (country)
- πBelgium
- πSpain
- πSpain
- πBelgium