Local Start-up Specialist, Dach - Duesseldorf, Deutschland - Allucent

Allucent

Geprüftes Unternehmen

Duesseldorf, Deutschland

vor 1 Woche

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 LSUS 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.

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

This position can be remote or hybrid, and based in
Germany or
Austria covering the DACH region.

Key Responsibilities

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 Startup 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, preclinical 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 sitespecific 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 sitespecific Essential Document Package and sending to sites

Requirements:

Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
25 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 German
Attention to detail
Able to perform well as a team member

Benefits

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 softskills and technical training via GoodHabitz and internal platforms

To all recruitment agencies:
Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes. #LI-JC1