Regional Regulatory & Study Start-Up Specialist (m/w/d) - home-based in Europe
- Experience Level
- Experienced (non-manager)
The IQVIA Sponsor-Dedicated Regulatory and Study Start-Up Team is obtaining the approvals for the conduction of clinical trials. Joining the team provides the opportunity to work with ethic committees' submissions as well as contracting and budget negotiations in the EMEA-region in a fast-paced, ever-changing environment. Within this opportunity you can work home based throughout Europe.
We seek highly motivated people who truly want to make a difference in the life sciences industry. At IQVIA, we look for the very best people and then give them meaningful work to do. We don’t simply think about careers, we think about contributions.
While projects vary, your typical responsibilities might include:
- Serve as Single Point of Contact in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and the client.
- Ensure adherence to standard operating procedures (SOPs), work instructions, quality of designated deliverables and to project timelines.
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Review, prepare and negotiate site contracts and budgets with sites. Prepare site regulatory documents, reviewing for completeness and accuracy. Perform quality control of documents provided by sites.
- Complete and submit approval request documents to Local Regulatory and Ethical Committees. Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Review and provide feedback to management on site performance metrics.
You should have:
- Bachelor’s Degree or apprenticeship in life science or a combination of education and experience
- At least 1 year experience in clinical research working with regulatory guidelines and tasks
- Fluent languages skills in German (at least C1 level), good skills in French and/or Spanish and additionally English are required
- Effective communication, organizational and planning skills
- Ability to work independently and to effectively prioritize tasks
- Ability to work on multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Very good IT skills including MS Office
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
Please apply with your English CV, motivation letter and your certificates and reference letters.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.