Overview:
The Clinical Trial Operations Associate supports the setup and management of clinical studies, focusing on financial and contractual aspects. This role ensures that investigator sites are equipped to enrol study participants by managing site budgets, negotiating and finalizing contracts, and maintaining compliance throughout the study lifecycle, from start-up to close-out. The position also contributes to clinical finance, documentation management, and inspection readiness, ensuring that records are complete, accurate, and accessible.
*Fluency in German and Italian is required*
Key Responsibilities
- Lead investigator site start-up activities, including the collection and submission of regulatory documentation
- Customize, review, and negotiate informed consent documents in collaboration with internal and external stakeholders
- Act as the primary point of contact for site Ethics Review Boards (ERBs) and Competent Authorities (CAs), where applicable
- Manage site budget discussions and contract negotiations, ensuring timely execution of agreements
- Track and ensure site compliance with required training and internal processes
- Drive start-up timelines in alignment with organizational priorities
- Maintain direct communication with investigator sites throughout start-up, maintenance, and close-out phases
- Proactively identify, communicate, and resolve issues that may impact timelines or compliance
- Ensure country-specific regulatory and data privacy requirements are accurately reflected in all submissions and systems
- Leverage prior site and review board experience to optimize efficiency for new studies
- Accurately populate internal systems to support trial and site performance tracking
- Adhere to procurement, legal, and financial policies and procedures
- Maintain Trial Master Files and document libraries for audit readiness and future reference
- Contribute to continuous improvement through feedback and shared learnings
- Support trial prioritization while anticipating and managing shifting priorities in a dynamic environment
Basic Qualifications
- Bachelor's degree, preferably in a scientific or health-related field
- Minimum of two years' experience in clinical research or a related field
- Strong understanding of the clinical development process and the critical importance of efficient site initiation
- Applied knowledge of project management principles and practices
- Experience working in a highly regulated, compliance-driven environment
- Ability to learn and adhere to financial, legal, and contractual guidelines
- Strong communication, negotiation, and problem-solving skills
- Excellent organizational and self-management capabilities
- Proficiency in German and English
