*Regional Regulatory & Study Start-Up Specialist (m/w/d) - sponsor dedicated, home-based in DACH*

We are currently hiring a Junior Regional Regulatory & Start-Up Specialist (m/w/d) to work in both fields of ethics and submissions as well as contracting and budget negotiations in our regional sponsor dedicated Regulatory & Start-up Department. Within this opportunity you can work home based throughout the DACH region.

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) and English, further language skills would be a plus
• 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.

#LI-KA1  #LI-TQ1

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.