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Una empresa innovadora busca un miembro clave para su equipo global de proyectos clínicos. Este rol implica apoyar el diseño de planes de desarrollo clínico, liderar la creación de documentos de estudio y participar en análisis de datos. Se valorará la experiencia en la industria farmacéutica y habilidades de liderazgo. La oportunidad ofrece un entorno colaborativo donde se fomenta el desarrollo profesional y la influencia en decisiones estratégicas. Si tienes pasión por la investigación clínica y deseas hacer una diferencia, esta posición es ideal para ti.
Mission
Tasks and Responsibilities
Core member of the Global Project Team and Strategic Clinical Team.
Supports the GCPL on the design of clinical development plans (focus on critical review of studies from competitors and aiming to optimize the clinical quality of the clinical design) for internal assets.
Provides regular scientific disease state updates, monitoring of the scientific aspects of the competitive landscape (maintain the scientific updates of competitors in targeted indications which will be the basis for Early Disease Roadmaps (EDR) and Target Product Profile (TPP) definition).
Core member Clinical Study Team.
Works cross-functionally within project / study teams to ensure the clinical strategy is translated into the development of the study concept document / synopsis, study protocol and related documents.
Leads the development of the clinical study synopsis with guidance from GCPLs or delegate and is responsible for accuracy of the scientific content of the study protocol, amendments, CSRs, ICF, CRF, as well as scientific / clinical content of key internal or external project-related documents (e.g., IB, Biomarker Strategy, briefing package for regulatory authorities, responses to Health Authorities for registration purposes and clinical studies approvals, ISE, ISS, publication).
Participates in Data Monitoring Committees.
Provides support for the definition and review of protocol deviations and leads the preparation of the conventions for the DRM. Supports the GCPL in data analysis and data review.
Participates in data analysis and provides support for content proposals for publications.
Education
Specific Knowledge