Designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at assigned sites.
Leading end-to-end study start-up activities, driving site selection, activation, and qualification assessments to ensure clinical trials launch efficiently and are compliance-ready.
Managing Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation is available, local contracts, and approvals meet stringent regulatory requirements.
Providing robust CRO oversight, monitoring external partner deliverables, tracking milestones, and escalation of any issues.
Acting as the primary contact and clinical trial expert for assigned study site personnel, for execution of the study
including training and coordinating certification of study site personnel.
Developing critical study documentation, including informed consent documents, patient instruction guides, and key documents for EC/CA submissions.
Collaborating cross-functionally with global, local, and virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross-functional team members, internal stakeholders, and external partners to achieve business goals.

A degree in a scientific discipline or related field (or equivalent combination of education and experience)
Proven track record in clinical operations or clinical trial coordination
Hands-on experience navigating the early phases of clinical trials, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions
Demonstrated experience in CRO oversight, with the ability to effectively monitor external partner deliverables and keep study timelines on track
Understanding of In Vitro Diagnostic Regulation (IVDR) frameworks alongside global standards such as ICH-GCP guidelines
Exceptional verbal and written communication skills (English) with a proven ability to build trusted relationships and influence cross-functional partners.
Nice to have: German-speaking skills

Clinical Site Manager – Study Start Up, In Vitro Diagnostic Regulation

Key skills