Aime Valdez Email & Phone Number

Distrito Nacional, Dominican Republic

Distrito Nacional, Dominican Republic

United States

Panamá

- Responsible for supporting the preparation and submission of regulatory documents to ensure compliance with local and international standards. - Managed regulatory dossiers, coordinated with cross-functional teams, and maintained up-to-date records of regulatory approvals. - Assisted in the development of regulatory strategies for clinical studies and provided guidance on regulatory requirements. - Conducted regulatory assessments and ensured adherence to Good Clinical Practices (GCP). - Regulatory SME: Puerto Rico, Dominican Republic and Panama. - Acting as Regulatory Analyst with experience in the drafting, revision, and finalization of informed consent forms, ensuring clarity, comprehensibility, and compliance with ethical and regulatory standards.

República Dominicana

Medical Intern in Hematology and Neurology: Delivered patient care, assisted with diagnostics and treatment plans, and collaborated with multidisciplinary teams. Gained hands-on experience in managing hematologic and neurological conditions in both inpatient and outpatient settings.

Dominican Republic

- Local Regulatory Support: Ensure compliance with local regulations and liaise with regulatory authorities for study approvals and follow-ups.- On-site Monitoring Visits: Assist CRA/CSM during monitoring visits to ensure protocol adherence.- IMP and Pharmacy Management (Blind): Oversee the handling and blinding of investigational medicinal products (IMP) and pharmacy management.- Feasibility Questionnaires Experience: Support to conduct feasibility assessments for clinical trials required by CRO/Sponsors in the site. - Regulatory Dossier and Document Management: Prepare and manage regulatory submissions, ensuring all documentation is accurate and up to date.- Patient Registration and Follow-up in Phase 3 and 4 Trials: Supervise the enrollment and tracking of patients in advanced phase trials, ensuring data quality.- Informed Consent Process: Facilitate proper informed consent according to ethical and legal standards.- Good Clinical Practices (GCP): Ensure strict adherence to GCP for quality and safety in studies.- eCRF and Medical Records Management: Monitor and update electronic case report forms and medical records, ensuring data integrity.- Local Regulatory Inspections: Prepare for and manage local regulatory inspections, ensuring compliance.- Serious Adverse Event Reporting (SAE): Accurately report SAEs in a timely manner, in line with international and local regulations.

Santo Domingo, Dominican Republic

-Teaching Assistant in Molecular Biology, Biophysics, Genetics, and Basic Life Support: Supported the delivery of both theoretical and laboratory sessions, ensuring students comprehended complex scientific concepts and applied practical skills effectively.-Support in Medical Simulation Workshops, BLS, and ACLS: Provided hands-on assistance in high-fidelity medical simulations, facilitating real-world clinical scenarios for Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS), enhancing student learning through immersive practice.

Santo Domingo, Dominican Republic

- Volunteer Coordination and Program Organization: Managed volunteer teams and organized workshops, diplomas, and courses on human rights and project development for non-profits. - Supported the “Closer to Europe” youth initiative by the European Union Delegation in the Dominican Republic, facilitating youth engagement and dialogue.

República Dominicana

Managed logistics and coordinated volunteer teams for large-scale youth events, ensuring smooth operations and active engagement with European Union policies and values.

Master'S Degree, Hospital Management And Administration

Expert, Clinical Trials And Medical Affairs

Doctor Of Medicine - Md, Medicine