Regulatory & Study Start-Up Specialist (m/w/d) - Frankfurt or home-office
If you thrive on work that has a broader purpose, you've come to the right place. As the world's largest bio pharmaceutical services provider, we've spent more than 30-years changing millions of lives for the better - all over the world.
We currently have an exciting opportunity as (Senior-) Regulatory & Start-Up Specialist (m/w/d) to work in both fields of ethics and submissions and contracting and budget negotiations in our Regulatory & Start-up Department. You can work in our Frankfurt office, alternatively you can work home-based throughout Germany. A specialization in contracting and budgets would be possible as well.
While projects vary, your typical responsibilities might include:
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
- 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.
- Distribute completed documents to sites and internal project team members.
- 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.
- Perform quality control of documents provided by sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
- Review and provide feedback to management on site performance metrics.
- 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.
You should have:
- Bachelor’s or higher level Degree in life science or a background in law
- At least 3 years of regulatory start-up/submission experience
- Fluent languages skills in German and good command of English
- 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.
We invite you to join IQVIA™.
Please apply with your English CV and motivation letter as well as 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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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