
Trial Operations Specialist
1 week ago
This role provides clinical trial capabilities in support of clinical development. The associate is accountable for ensuring investigator sites meet requirements to enroll study participants into clinical trials from budgets and contracts perspectives and supports ongoing budgets and contracts activities during site maintenance and close-out.
The associate communicates 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 Trial Responsibilities:- Initiate investigator site activities, including communicating and negotiating budgets and contracts with site personnel, service providers, and internal teams.
- Negotiate and obtain fully executed contracts, and effectively drive timelines aligned with company priorities.
- Responsible for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility.
- Ensure site initiation and maintenance activities comply with local/regional requirements, data privacy requirements, and Lilly quality standards.
The associate ensures that all financial transactions are accurate and compliant with relevant laws and regulations. This includes collecting and administering financial data from contracting partners and vendors, ensuring finance-specific requirements are administered in budget and contract documents, supporting contracting partners, vendors, and internal stakeholders during the payment process, and identifying, communicating, and resolving issues related to payments.
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.
- Identify, communicate, and resolve issues related to payments.
Minimum Qualification 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 compliance-driven environment.
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