Majadahonda, Community of Madrid, Spain
Contracts Lead working with phase 3 oncology studies and overseeing EU countries. Leading contract and budget negotiations with investigator sites for initial agreements and amendments, up to full execution. Managing budget, operational, and non‑legal contract issues raised by sites or CROs. Cross-Functional Collaboration with study teams, Legal, budget specialists and country teams. Handling master clinical trial contracts negotiations with Spanish sites.
As Contract Associate I’m responsible for the commercial relationship with sites involved in clinical trials including work from contract and amendment language, budget negotiation within the established timeline parameters and being capable to prioritize as the needs arise raising issues before they become critical. As Contract Associate I must ensure the success of the contracts and amendments negotiation and on-going management of clinical trial agreements with investigative sites. Through teamwork with the different departments I help estimating an accurate forecast of contract execution timelines and help to ensure country specific laws and regulations are followed in order to minimize risks in clinical trials. Some general tasks are the following: Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines. Provides necessary documents to investigative sites in order to allow contract negotiations. Evaluates priorities and quickly readjusts priorities with the changing needs of business and the client. Manages multiple projects at the same time following client priorities. Appraises contracts for completeness and accuracy and ensures adherence to department guidelines. Generates ideas and solutions to improve requested contract/budget changes and to improve the contract management in different countries, such as Spain and Italy Executes documents that are complete and accurate and delivers them within shorter timeframes. Creates good relationships with investigative sites and makes sure the negotiations are smooth and fast.
Parexel is a global provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval. As Site Contracts Leader for Spain my duties are: • Negotiating and dealing with on-going management of contracts with clinical investigative sites and other biotechnology and pharmaceutical project-related contracts. • Sponsor's Budget detailed review and discussion of discrepancies with Study Project Leaders • Handling of contract amendments or disputes, and escalating issues identified during the contract negotiation process that could affect quality and timeliness of the site contracting deliverables or that could impact client or site relations. • Working within the defined client “fallback” or approval parameters to manage and resolve significant contract changes requested by the clinical investigative site. • Participating in client, investigator and team meetings, as required.