IQVIA Biotech is looking for an experienced Clinical Study Start-up professional in Germany or Austria to join our Study Start-Up department. The Study Start-up Specialists are responsible for conducting and facilitating specific start-up activities that may include site identification, feasibility, essential document collection and review, ICF customization, EC submissions, negotiation of Clinical Site Contracts, regulatory green light packages mainly for Germany, but also in Austria and Switzerland.
Responsible for Ethics Committee (EC) submissions and submissions to local authorities as e.g. radiation board in Germany (BfS).
Create, review and customization of country/site specific Informed Consent Forms (ICFs).
Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
Review and provide feedback to SSU manager on site performance metrics.
Work with regulatory team members and SSU manager to secure authorization of regulatory documents.
Responsible for the translation and co-ordination of translations for documents required for submission.
Responsible for liaising with local CRA/CTM, Contract Specialist, and Regulatory Lead to enable a rapid clinical trial start up.
Review and negotiate site regulatory documents and contracts with sites for agreement on wording and budgets. This will be done with consultation from the regulatory lead and contracts lead regionally.
Work with legal team members and SSU Manager to secure authorization of contracts.
Inform team members of completion of regulatory and contractual documents for individual sites.
May participate in feasibility and/or site identification activities.
Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
Collects and reviews initial regulatory packets and site contracts for investigator sites.
Assures that SSU functions interface effectively with all other key operating departments within IQVIA Biotech. Working with Clinical Operations, Project Management, Site Identification, additional SSU specialists, Regulatory and Contracts group on SSU project specific status and deliverables.
Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research.
Facilitates process improvement efforts both within the department and in cooperation with other departments.
This role is permanent, full time and home based in either Germany or Austria.
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.