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
Basic Qualifications
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
Skills
Skills: Clinical Trials German English Negotiation
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