Gabriela Alejandra Jimenez Arvelaez

Negotiate business and legal terms in model agreements, negotiate vendor master agreements, review client agreements to identify appropriate flowdown terms for vendor agreements. Act as liaison between project management and Global Vendor Management to ensure appropriate sourcing and category management. Provide guidance and advisory to the project and study teams to better select and negotiate with vendors which adapt to the protocols, and offer better solutions and delivery timelines to their needs.

Site identification and selection management Regulatory and Start-Up phase management for selected sites Clinical Trial Agreement preparation, negotiation and execution (including partial translations) Site activation and therapeutic, protocol and clinical research training to selected sites Monitoring activities, EDC review and site close out. TMF – CTMS maintenance.

Support global standards for Records Management activities. Actively support activities associated with managing records within a global network of programs/systems for customer's Trial Master File documents. Performing Quality Control, File Review, and filing in eTMF, in systems such as ELVIS, and Wingspan. Data entry in systems like CTMS, ensuring effective security, storage, and retrieval of all proprietary and client information following established SOPs

Drafting and negotiation of Clinical Trial Agreements amendments and budgets. Experience in direct end-to-end negotiation with sites regarding budgets or contract changes, till the execution of the amendments and filing and data entry the internal systems. Tracking work, reviews, and approvals, adhering to established processes. Ensuring the delivery of final Amendments, Side Letters, Assignments, and Budgets on time and as scheduled. Follow-up of processes, project plans, and completion.