
Clinical Trial Operations Specialist
2 weeks ago
Job Overview
We are a global healthcare leader with a presence in multiple locations worldwide. Our team of over 2000 employees delivers innovative solutions across various business service functions.
In this role, you will provide clinical trial capabilities in support of clinical development, ensuring investigator sites meet requirements to enroll study participants. You will be responsible for the execution of budgets and contracts, as well as activities related to clinical finance and records management.
You will also contribute to the creation of a complete, accurate, and readily available Trial Master File, ensuring inspection readiness. Additional local responsibilities may be required as needed.
- Initiate investigator site activities, including communicating and negotiating budgets and contracts with site personnel and internal teams.
- Negotiate and obtain fully executed contracts, effectively driving timelines aligned with company priorities.
- Meet and exceed goals for clinical trial initiation.
- E nsure site initiation and maintenance activities comply with local/regional requirements, data privacy requirements, and quality standards.
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites regarding budgets and contracts activities during maintenance and close-out.
- Identify, communicate, and resolve issues related to budgets and contracts.
Clinical Finance Responsibilities:
- Collect and administer financial data from contracting partners and vendors.
- Ensure finance-specific requirements are administered in budget and contract documents.
- Support contracting partners, vendors, and internal stakeholders during the payment process.
Requirements:
- Bachelor's degree preferably in a scientific, health-related, engineering, economics, or project management field.
- Two years of clinical research experience (CRO, sponsor, or healthcare service provider) or relevant budget and contract negotiation experience preferred.
- Understanding of the overall clinical development paradigm and the importance of efficient site activation.
- Appreciation of / experience in a compliance-driven environment.
- Ability to learn and comply with financial and legal guidelines and policies (budget and contract).
- Effective communication, negotiation, and problem-solving skills.
- Self-management and organizational skills.
- Language capabilities: English essential.
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