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Study Start Up Specialist, office based in Hamburg

full-time TFS Hamburg

The Study Start Up Specialist (SSU Sp) is part of Site Management and Start Up Unit, within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.

The SSU Sp must contribute to ensure the planned start up plan is executed maximizing the recruitment window of assigned studies. As part of the job function will perform activities associated with feasibility and site identification, study site initiation process, interact with Ethics Committees or deal with investigator contracts.

Essential job functions:

  • Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
  • Collect, review, approve process and track regulatory & investigator documents required for study site activation.
  • Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to the EC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees.
  • Collaborate with Regulatory department regarding HA/CA submission/notification.
  • Main responsible of ensuring the quality control of documentation included in any submission/notification.
  • Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
  • Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
  • Participate on site evaluation and feasibility process for assigned projects.
  • Review and provide feedback to management on site performance related to start up activities.
  • Ensures all start up information & requirements are kept up to date in the central repository for project teams Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
  • Assist in status reporting
  • Responsible of Contract Trial Agreements handling and negotiation in coordination with Legal advisor and SSU Lead.
  • Ensure all Start Up documentation is submitted properly and on time to the Trial master File.
  • Assist the SSU Lead / Project manager ensuring the Project is properly set up in CTMS and all information related to start up activities is properly updated.
  • Support the SSU Lead / Project Manager during the Greenlight and site activations process
  • Support the SSU Lead / Project Manager with status of start-up progress.
  • Contribute to the continuous improvement of clinical operations through participation in working teams/ initiatives as needed
  • Assist in activities associated with audits and regulatory inspections
  • May also be appointed as CTA in some projects and conduct CTA tasks such as SMF and TMF set up and maintenance, Coordinate study supplies, Drafts and/or assists with the preparation of trial-related documents, tools and templates

  • Bachelor’s Degree preferred
  • Good knowledge of GCP/ICH guidelines
  • Good Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
  • Minimum 1-3 years of relevant clinical experience
  • Previous experience with investigator start-up documents and investigative sites is preferred
  • Good written and communication skills
  • Good organizational skills and experience working with cross functional teams
  • Strong software and computer skills
  • Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
  • Travel within this position is limited
published: June 21, 2018

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