Senior Site Start-Up Associate, Belgium
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Senior Site Start-Up Associate to join our team! This is a permanent role to be home based in Belgium.
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As a Site Start Up Associate you'll be accountable for:
- Quality deliverables at the country level for site start-up in one or more components.
- Following project requirements and applicable country rules.
- Proactively forecasting submission/approval timelines and ensures they are adhered to.
- Local Clinical Trial Applications Specialist - may serve as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Preparing and submitting Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Preparing ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities within the country; includes safety notifications as required by local rules.
- May provide regular updates of country specific information on the clinical trial application database on SharePoint.
- Submitting end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities in the specified country according to national timelines.
- Performing essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Local Investigator Contract and budget negotiator
- Producing site-specific contracts from country template
- Submitting proposed contract and budget for site
- Negotiating budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
- Preparing checklist for IP release according to country regulations.
- Ensuring accuracy and completeness of trial master file documents submitted during start-up and perform a QC review of files before transfer to Maintenance for filing in TMF
- Providing all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up
- Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies.
- Liaising with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Providing country-level intelligence on site start-up
- Ensuring that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
- Setting up and maintaining a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
- Setting up and maintaining details of existing site and institution contract requirements, as well as the necessary templates and fees, on the clinical trial application database on SharePoint.
- Providing quality review of the informed consent and adapts the template as appropriate.
- Ensuring documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
You’ll need this to be considered:
- Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required.
- Thorough knowledge of ICH/GCP and/or ISO14155 and local regulatory authority drug research and development regulations required. Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out
- Prior experience in submissions to EC and CA in Belgium
- Experience serving as primary liaison for site start-up and site start-up management
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Fluent verbal and written English as well as the local language required for clinical trial submissions. French is required for this role
- Excellent team player, collaborative; Accountable, dependable and strong commitment; Is customer-service focused in approach to work, both internally and externally
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Strong verbal and written communication and negotiation skills; Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Maintains a positive, results orientated work environment
You must be eligible to live and work in Belgium in order to apply for this role