Clinical Trial Monitor
hace 6 días
En Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan cambios significativos. Aportamos un toque humano a cada tratamiento en el que somos pioneros. Únete a nosotros y marca la diferencia.
Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Act as one of the points of contact at a Site level for internal and external stakeholders.
Key Responsibilities and Major Duties
- Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
- Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
- Develop Site relationships (incl. Contract Research Organization related issue management and non
- registrational /Investigator Sponsored Research Studies)
- Recommends sites during the site feasibility and/or site selection process
- Conducts pre-study visit as appropriate
- Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation
- Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
- While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
- Serve as a point of contact for Sites
- Provides trainings to sites
- Performs site closure activities when all required protocol visits and follow
- up are completed
- Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities.
- Oversees activities of site personnel over whom there is no direct authority.
- Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
- Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
- Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
- May support Ethics Committee submission, ICF review, collection of documents to/from site
- May support ensuring access to eDC and BMS / vendor systems is available for clinical trial site personnel
- May support equipment calibration and tracking
- May support preparation of Study Initiation Visit materials
Bachelors or Master’s degree required. Field of study within life sciences or equivalent
En todo el mundo, nos apasiona tener un impacto en la vida de los pacientes con enfermedades graves. Con el poder de aplicar nuestros talentos individuales y perspectivas diversas en una cultura inclusiva, nuestros valores compartidos de pasión, innovación, urgencia, responsabilidad, inclusión e integridad sacan a relucir el mayor potencial de cada uno de nuestros colegas.
Bristol Myers Squibb reconoce la importancia del equilibrio y la flexibilidad en nuestro entorno de trabajo. Ofrecemos una amplia variedad de beneficios, servicios y programas competitivos que brindan a nuestros empleados los recursos para perseguir sus metas, tanto en el trabajo como en su vida personal.
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