Madrid, Community of Madrid, Spain
I have a BSc Degree in Biochemistry and during my studies I gained knowledge in different fields such as Cellular Biology, Immunology, Clinical and Pharmaceutical Biotechnology. I worked on my final degree project at the Physics-Chemistry Department in association with Instituto de Investigación Hospital 12 de Octubre (i+12). Moved by my interest in education, I spent some time as Teacher Assistant. Following this, I decided to move back to the scientific research area and continued my education in the clinical field by completing a Master´s Degree in Clinical Trials Monitoring and Management. I joined Pivotal in February 2018, as CRA Trainee where I received training related to all main departments in a CRO, like Human Resources and Talent Acquisition, Start-Up, Clinical Operations, Data management, Pharmacovigilance. After this, I joined IQVIA on January 2019 as CRA I, working under FSP model directly with Roche client. But I redirected my professional carrer and I changed my role in IQVIA starting as Regulatory and Start-Up Specialist I, where I promoted to RSU Specialist II on 2021. Finally on 2023 I was hired by ICON Strategic Solutions with the role of Clinical Operations Manager on behalf of MSD and, on 2024 I was part on the internal MSD staff under the same role. I have more that more than 5 years’ experience both in CRO and Pharma environments. Experience in regulatory, monitoring and managing clinical trials in phases I-II-III in a wide range of therapeutic areas, including ophtalmology, internal medicine, oncology, neurology, cardiovascular, rare diseases, oncology, and infectious diseases. Thorough knowledge of all phases of the project lifecycle, including start-up, clinical trial initiation, monitoring, interim and final data base cleaning and close out activities. Enthusiastic team player, with excellent communication skills and ability to work in a fast paced and changing environment.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck Sharp & Dohme (MSD) policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. RESPONSIBILITIES -Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and RAs in submission and approval related interactions. - Required to in/directly influence investigators, external partners and country operations to adheres to budget targets and agreed payment timelines. - Oversees and coordinates ancillary supplies management, imp and exp requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. -Provides support and oversight to local vendors as applicable. - Collaborates closely with HQ to align country timelines for assigned protocols. -Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. -Contributes to the development of local SOPs. Oversees CTCs as applicable. -Manages country deliverables, timelines and results. -Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority. -Executes and oversees clinical trial country submissions and approvals -Oversees and tracks clinical research-related payments. -Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Continue and take expertise of the responsibilities assigned to RSU Specialist I below • Involvement in new resources assignment • Involvement in new candidate referral program. • Mentoring new colleagues, providing guidance in order to assure all tasks related to a complete RSU cycle will be correctly performed and will be final according to agreed timeliness. • Act as Subject Matter Expert on electronic Trial Master File Master (eTMF): providing training to department colleague regarding to Wingspan TMF, Intelligent eTMF and Sponsor specific TMF; obtaining weekly reports to analyze metric compliance and lead meeting with department managers. • Act as Subject Matter Expert in OneNote department data base: assure all relevant information for daily work is included in a proper manner, giving specific trainings and resolving doubts. • Act as Subject Matter Expert in DocuSign application: providing support with this electronic signature system and resolving daily issues.
• Prepare, review and coordinate, local regulatory submissions • Provide, local regulatory strategy advice (RA &/or EC) to internal clients. • Provide project specific local start-up services and coordination of these projects. • Contact with Principal investigators and study staff for submission activities and doc collection • Key-contact at country level for either Ethical or Regulatory submission activities • Coordinate, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; • Develop country specific Patient Information Sheet/ICF documents. • Import- Export licenses application regarding to biological samples • Lead site specific contract templates preparation according to local law and Sponsor´s key clauses • Lead Grant Plan Budget review and adaptation • Lead contract and budget negotiation with sites • Lead contract and budget amendments/addendums • Prepare and negotiate Ancillary Service Agreement with external sites • Collection of essential documents from sites needed for Site Initiation Visits and site activation • Obtain Essential documents Package (EDP) approval • Lead site activation process in collaboration with CRAs and CTAs • Prepare and send to site the Investigator Site File and the Pharmacy file which include all documents needed for Site Initiation Visit. • Prepare and send patient recruitment material and patient study materials • Performed complete handover to clinical team (CRAs and CTAs) • Work in Amendment/Substantial modifications submission and notifications to Spanish RA and EC. • Achieve IQVIA’s target cycle times for site activation • Enter and maintain trial status information relating to start-up activities onto internal tracking databases in an accurate and timely manner • Archive all regulatory related documents needed on electronic Trial Master File (eTMF), obtain reports and have the filing control.
• Review and/or input to study protocol, CRF and validation tools • Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc. • Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country • Conduct of site qualification visits (pre-study visits) • Conduct of site initiation- and site close out visits • Conduct of regular monitoring visits • Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to • Writes a site visit report after each type of visit, in which the tasks performed during the visit and any problems encountered are reported, along with follow-up on any outstanding issues. This report must be completed with the appropriate logs (CRF transmission form, drug accountability log, samples log etc.) according to the study and the Sponsor’s requests • Writes a corresponding site visit follow-up letter for the purpose of on-site quality optimization • Distributes any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.) • Responsible for the quality of data from my own sites • Resolves questions/ issues with investigator/trial staff including query verification • Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date and ready for a study audit and/or inspection • Participates in investigators meetings and assists in the preparation of these meetings • Performs activities in other clinical research areas according to the directive of superior
Receiving training related to all main departments in a CRO, Human Resources and Talent Acquisition, Start-Up, Clinical Operations, Data management, Pharmacovigilance. Performing Start-Up, Clinical Administrative, Co-monitoring, and Data Management tasks. Therapeutic Area/s: Oncology and Internal Medicine (+Observational studies) RESPONSIBILITIES • Human Resources meeting attendance and support • Support in selection of new candidates to fill vacant positions as CRA and CTA trainees • Review new candidates CVs and previous experience • Involvement in face-to-face and telephone interviews. • Good documentation practices (to adapt an ICF, to review a protocol/study manual) • Feasibilities implementation and follow up • Preparation of essential documents packages (including investigators documents) • Delivery and follow up of the documentation for the investigators signature • Development of contact tables • Clinical study authorization process including CA/EC clarifications request step • Contract Management • Develop, understand and update study documents trackers • Study files assembling and maintenance • Study files quality checks • Process revision of the study status tracker • SAE review and processing • IMP process revision: Request, stock control, traceability management. devolution and destruction • Study material process: Request, stock control and issues management • Processing "queries" in paper and electronic • Regulatory post-authorization notifications including annual follow-up reports. Delivery and content revision • Sites/investigators payment management • Protocol deviations management and related procedures • Remote monitoring • Pre-selection visit/qualification visit • Presential monitoring: Initial, monitoring and closed visits
Working on my final degree project at the Physics-Chemistry Department of the Faculty of Chemical Sciences in association with "Instituto de Investigación Hospital 12 de Octubre" (i+12). There, I participated in a research project connected with University of Oxford based on the use of microfluidic techniques to develop a new method of vesicle formation that uses water-in-water (w/w) emulsions as templates.