Site Specialist II (German speaker)

Job description

take responsibility for regulatory affairs deliverables, applying your skills to ensure quality and efficiency ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Site Specialist II at ICON , you will play a key role in supporting clinical trial sites in DACH (Germany, Austria and Switzerland) , helping studies progress efficiently through start-up, activation and ongoing site management. Working independently across assigned sites and studies, you will act as an important operational point of contact for sites and internal study teams, ensuring documentation, regulatory activities, systems and key milestones are managed accurately and in line with study requirements. This is an excellent opportunity for someone with hands-on EU Clinical Trials Regulation (EU CTR) experience who understands the requirements of working with clinical trial sites in Germany or Austria. What You Will Do You will independently manage a range of site-level activities, supporting efficient study start-up and/or maintenance throughout the study lifecycle. Key responsibilities include: Coordinating the collection, review and maintenance of essential site documentation, ensuring completeness, accuracy and compliance with study and regulatory requirements. Supporting site start-up and regulatory activities in accordance with EU CTR requirements and/or CTD requirements in Switzerland . Acting as a key operational contact for DACH investigator sites, providing guidance on documentation, systems, timelines and study processes. Tracking site progress, milestones and outstanding actions, ensuring information is accurately maintained within relevant clinical trial management systems. Working closely with Site Activation, Regulatory, Clinical Operations and other cross-functional teams to identify and resolve issues that could impact site timelines. Supporting ongoing site maintenance activities throughout the study lifecycle. Proactively identifying potential delays or operational challenges and driving appropriate follow-up with sites and internal stakeholders. Contributing to process improvements and sharing best practices across the wider team. Providing guidance and support to more junior colleagues where appropriate. Your Profile: You will bring previous clinical research experience together with a strong understanding of site-level processes and European clinical trial requirements. Required qualifications and experience: Bachelor’s degree in life sciences, healthcare or a related discipline, or equivalent relevant clinical research experience. Previous experience in site support, site activation, study start-up, regulatory or clinical trial operations within a CRO, pharmaceutical company or similar clinical research environment. Hands-on experience working with EU CTR processes and requirements. Good understanding of clinical trial documentation, GCP and site-level regulatory requirements. Fluent German and English , with strong written and verbal communication skills. Strong organisational skills, with the ability to independently manage multiple sites, deadlines and competing priorities. A proactive, solution-focused approach and confidence working with investigator sites and cross-functional teams. Highly desirable: Experience working directly with clinical trial sites in DACH Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee? Please click here to apply