(Sr.) Site Activation Specialist (m/w/d)

In this role you drive country-level site activation for clinical research, ensuring compliance and timely start-up activities. You will collaborate with cross-functional teams, regulatory bodies, and investigators to deliver quality regulatory documents, contracts, and approvals. The position emphasizes adherence to SOPs, project timelines, and risk management, while supporting a flexible, home-based work setup in Germany. You will help enable efficient trial initiation and site performance, contributing to IQVIA’s mission to accelerate patient outcomes. This is a hands-on, impact-focused role with growth and mentoring opportunities within a dynamic team.

• Flexible working schedule
• Home-office
• Competitive salary
• Bonus system
• Pension
• Career growth opportunities

• Serve as single point of contact for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and client.
• Ensure adherence to SOPs, work instructions, quality of deliverables and project timelines.
• Perform regulatory, start-up and maintenance activities according to applicable regulations and SOPs.
• Review, prepare and negotiate site contracts and budgets with sites.
• Prepare site regulatory documents and ensure completeness and accuracy.
• Perform quality control of documents provided by sites.
• Submit approval documents to Local Regulatory and Ethics Committees and ensure approvals and IP Release are granted.
• Track progress and execution of contracts, regulatory, ethics, ICF and IP Release documents within timelines.
• Maintain internal systems, databases and tracking tools with project information.
• Review and establish project planning and timelines; ensure overall efficiency and contingency plans.
• Provide feedback on site performance metrics to management.

• University Degree in life science or related discipline or apprenticeship in health care or paralegal
• Clinical research experience, preferably in study start-up or an equivalent combination of education and experience
• Knowledge of GCP and ICH guidelines
• Fluent German (C1) and good command of English
• Strong written and verbal communication skills
• Attention to detail and ability to multitask and prioritize

• Effective communication
• Attention to detail
• Multitasking and prioritization
• Regulatory start-up knowledge
• Site contracts and budgets
• Regulatory document preparation and QC