Alícia Ovide

Led the full site activation process, ensuring compliance with EU-CTR and local regulatory guidelines. Managed the negotiation and execution of site contracts and budgets, acting as the main point of contact for resolving contractual and regulatory blockers. Maintained accurate tracking and version control of all documents via TMF, CTMS, and contract management systems.

Acted as the Single Point of Contact for investigative sites during start-up and maintenance phases, managing regulatory submissions to AEMPS and CEIm. Oversaw the collection, review, and tracking of essential documents, ensuring alignment with ICH-GCP, EU regulations, and sponsor SOPs. Participated in site contract and budget negotiations, resolving contractual issues for timely site activation.

Led end-to-end regulatory start-up activities for multiple clinical trials, acting as SPOC between sites, regulatory bodies, and internal teams. Managed submissions to AEMPS and Ethics Committees, overseeing contract and budget negotiations with sites. Supported TMF management, feasibility activities, and site readiness tracking.

Managed the drafting, negotiation, and revision of Clinical Trial Agreements (CTAs), CDAs, and indemnification letters, ensuring ICH-GCP compliance. Supported regulatory submissions to AEMPS and Ethics Committees, maintaining contract tracking systems and site document files. Collaborated with stakeholders to address contractual delays and resolve legal discrepancies efficiently.

Provided administrative assistance directly to the head of the legal department, managing calls and correspondence from internal and external stakeholders. Ensured efficient information flow and processed confidential information, assisting in the development of administrative systems. Drafted routine correspondence related to work assignments.

Assisted volunteers and lawyers in the immigration law department, performing a wide range of office support and administrative functions. Provided guidance to new clients in Spanish and English, translating official and legal documents. Acted as a support point between official organizations and the immigration law department.

Performed administrative assistant duties within the Au Pair program. Supported program operations and participant needs.

Assisted in a merge and acquisition project between two international bank entities, researching, compiling, and organizing information for reports and meetings. Assisted in preparing presentation materials and carried out quality control for outgoing documents. Maintained both paper and electronic files.

Provided office support including customer and employee support, maintaining well-organized files and records of business activity. Researched company data and interacted with clients both on the phone and in person.

Completed a program focused on clinical trial assistance, gaining knowledge in the operational aspects of clinical research. Developed skills relevant to supporting clinical trials effectively.

Obtained a law degree, providing a strong foundation in legal principles and regulations. Developed analytical and critical thinking skills applicable to various professional fields.

Completed secondary education with a focus on classical studies. Gained a broad educational background in humanities and sciences.