Ana Simas

Experience

• 

  Universidade de Aveiro

  Oct 2012 - Sept 2013

  Associate Project Manager [volunteer activity]

  Organised and transcript Focus Group meetings, elaborated meeting minutes, for the observational study:“Development of a Questionnaire to Assess the Knowledge, Beliefs, Attitudes and Motivations of Patients, Physicians and the Lay Community Towards Clinical Research and Participation in Clinical Trials in Portugal” (Investigator: Ana Maria Nogueira, MD). Co-administrated the Training Programme in Pharmaceutical Medicine Website.

• 

  Instituto Português de Oncologia do Porto

  Sept 2013 - Jun 2014

  Study Coordinator Trainee (Oncology)

  Assisted in the coordination of 15 clinical trials in Oncology (Lung cancer, Prostate cancer, Renal cell carcinoma, Ovarian cancer, Paediatrics, and Pneumonia)Developed SOPs (which specified the Investigator, Clinical Research Coordinator, Study Nurses and Pharmacists’ roles and responsibilities in the Clinical Trial, in each step of patient participation).

• 

  Champalimaud Foundation

  Nov 2014 - Nov 2019

  (2014 to 2019)I managed Ethics Commission and AB submissions, developed SOPs, and participated in feasibility, and site qualification activities. I Managed study start-up activities, including reviewing and adapting informed consent forms to meet regulatory and site-specific needs, budget reviews, and clinical study insurance and study agreement negotiations. In study coordination, I specialized in Phase III/IV trials for lymphoma, multiple myeloma, and dermatology, performing data entry, study document management, stakeholder communication, and patient visits preparation. I ensured strict protocol adherence by coordinating patient visits and handling source documentation, Investigator Site Files, and eCRF completion in EDC systems (IWRS, eProtocol Inquiry, Trial Manager).I also trained team members and prepared for monitoring visits, contributing to seamless trial execution and regulatory compliance. Show less

  • Senior Clinical Research Coordinator

    Nov 2017 - Nov 2019

  • Clinical Research Coordinator

    Jun 2015 - Oct 2017

  • Clinical Research Coordinator Trainee

    Nov 2014 - May 2015
• 

  CTI Clinical Trial and Consulting Services

  Nov 2019 - May 2021

  Regulatory Affairs Study Start Up Specialist I

  I handled comprehensive regulatory submissions for RWE studies, from initial submission to study closure. I ensured compliance by country-adapting, and translating informed consent forms, and performing quality control on regulatory documents. My responsibilities included preparing Clinical Trial Applications and drafting critical documents.I served as the primary contact for sponsors, vendors, ethics committees, and sites, managing study timelines, document updates in eTMF, and advising clients on regulatory strategies. Show less

• 

  IVI RMA GLOBAL

  Jun 2021 - Oct 2024

  Research Manager

  As Research Manager, I led and mentored the Research Coordinator team, overseeing study conduction to ensure high-quality, compliant operations. I managed study start-up processes, advised investigators, coordinated with local and central authorities, and ensured rigorous review of protocols, informed consent forms, and patient materials. I effectively negotiated budgets with vendors and maintained oversight of financial agreements. My leadership contributed to achieving strong results in an internal audit of the research center, affirming our commitment to regulatory standards. This role allowed me to grow significantly as a leader, fostering both team development and study excellence. Show less

• 

  Freelance

  Oct 2024 - now

  Ethics & Clinical Research Consultant

  Consulting services:- Regulatory & Ethical Compliance Support: Provide expert guidance on regulatory submissions, Informed Consent Form review, Ethics Committee approvals, and adherence to EU and local regulations, ensuring compliance across all stages of clinical studies, from start-up to end of trial. - Clinical Study Conduction: Offer strategic advice on protocol development and study conduction, optimizing study operations and ensuring protocol adherence.- Training & Advisory: Develop SOPs to support research teams, ensuring consistent compliance and efficient study execution while navigating regulatory challenges. Show less

• 

  Ana Simas

  Jan 2025 - now

  Mentora & Consultora de Estratégia de Carreira

  Ajudo profissionais a desbloquearem o seu potencial, saírem da estagnação e, darem os primeiros passos rumo à realização que procuram.Ajudo organizações a melhorarem a sua comunicação interna e relação com colaboradores.Visita a minha página, para mais informação.---I help professionals unlock their potential, break out of stagnation and take the first steps towards the fulfillment they seek.I help organizations improve their internal communication and employee relations.Visit my website or service page for more information. Show less

• 

  Autônomo

  Mar 2025 - now

  Estou disponível para dinamizar workshops e palestras em:Comunicação profissional eficienteDesenvolvimento de plano de carreiraÉtica & investigação clínicaComunicação em saúde---I am available for workshops or lectures on:Professional and efficient communication Career Roadmap DevelopmentEthics & clinical researchHealth CommunicationDinamized the Workshop “Informed Consent & Participating in Clinical Trials” for Sjögren Europe’s General Meeting, Dec 2024 (find here the agenda: https://www.segm2024.com/wp-content/uploads/2024/12/Program_SEGM2024_Lisbon.pdf) Show less

  • Formadora | Trainer

    Nov 2024 - now

  • Membro da Comissão de Ética para a Saúde do IVI Lisboa e Ginemed

    Mar 2025 - now