Clinical Trial Project Manager
Professionals with a Bachelor’s or Master’s degree in Life Sciences (Biology, Biochemistry, Pharmaceutical Sciences, or related fields), 3 to 5 years of proven experience in clinical project management or as a Clinical Research Associate (CRA), solid and up-to-date knowledge of ICH-GCP guidelines (including ICH E6 R3) and European regulations (CTR/GDPR), demonstrated expertise in financial and budget management (cost forecasting and vendor negotiation), a strong ability to anticipate risks and engage in proactive planning, digital literacy in CTMS, EDC, MS Project, and Excel, high capacity for leading multidisciplinary teams, strategic vision, resilience, and mandatory fluency in Portuguese and English (written and spoken). Responsibilities include overseeing all phases of Phase II–IV clinical trials, from research site selection and regulatory submissions through database closure and final report issuance, serving as the primary point of contact and directly responsible for project planning, execution, and delivery, acting as a strategic liaison between the sponsor, regulatory authorities, ethics committees, CROs, CDMOs, and research teams, ensuring strict adherence to timelines, budgets, and recruitment metrics in accordance with international quality standards, monitoring project budgets, managing contracts, and processing investigator payments, identifying and mitigating risks by anticipating budget deviations, and ensuring that all activities comply with Good Clinical Practice (GCP/ICH), protocols, and applicable national and international legislation.