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 enroll 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 English and Italian is required*
Key Responsibilities
- Initiate and oversee site start-up activities, including budget development and contract negotiation with investigator sites, vendors, and internal teams.
- Secure fully executed contracts in alignment with project timelines and organizational priorities.
- Support timely site activation and ensure compliance with regional regulations, data privacy standards, and company quality requirements.
- Maintain ongoing communication with sites regarding budget and contract matters during study maintenance and close-out.
- Identify and resolve financial or contractual issues efficiently.
- Ensure all local and regional legal, financial, and data protection requirements are reflected in study documentation.
- Use prior site and ethics/review board experience to streamline new negotiations.
- Accurately update internal tracking systems and ensure Trial Master File documentation is complete and inspection-ready.
- Collaborate with internal stakeholders to improve processes and share best practices.
- Adapt to shifting priorities and support trial prioritization efforts.
- Collect and manage financial information from sites, vendors, and other contracting partners.
- Ensure all financial obligations and requirements are properly incorporated into budget and contract documents.
- Communicate financial expectations between internal teams and external stakeholders.
- Provide support during the payment process and assist in resolving payment-related issues.
- Contribute to financial tracking and compliance in alignment with corporate and regulatory guidelines.
Qualifications
- Bachelor's degree in a relevant discipline such as life sciences, healthcare, business, economics, engineering, or project management.
- Minimum of two years' experience in clinical research (CRO, sponsor, or healthcare setting) or in budget and contract negotiation.
- Strong understanding of the clinical development process and site activation requirements.
- Experience working in a compliance-focused or regulated environment.
- Ability to learn and adhere to financial, legal, and organizational policies.
- Excellent communication, negotiation, and problem-solving skills.
- Strong organizational and time management abilities.
- Fluency in English and Italian is required.
