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.
- Performs the startup activities of assigned studies within The Netherlands and Belgium, 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 theEC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees (for The Netherlands and Belgium)
- Collaborate with Regulatory department regarding HA/CA submission/notification (for The Netherlands and Belgium)
- Main responsible of ensuring the quality control of documentation included in any submission/notification.
- Adapt Informed Consent documents according to local law in The Netherlands or Belgium and document the process following guidelines and SOPs.
- Ensure contracts are fully executed, regulatory documents and approvals are granted, IPRelease 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
- Good knowledge of GCP/ICH guidelines
- Good Knowledge of applicable of applicable local laws in The Netherlands and Belgium
- Minimum 1-3 years of relevant clinical experience
- Previous experience with investigator start-up documents and investigative sites is preferred
- Excellent written and spoken communication skills: at least English and Dutch, preferably French as well
- 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 good understanding of working in a team environment
- Travel within this position is limited
- Entrusted working time
- Corporate Pension Plan
- Global General Liability Insurance
- Global Travel Insurance