Clinical Trial Monitor

hace 2 semanas

Madrid, España Bristol Myers Squibb A tiempo completo

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Clinical Trial Monitor will be based in Madrid and be responsible for the oversight of the progress of clinical trials in Madrid and some other area as per business need, ensuring clinical trials are conducted and documented following GXPs, regulatory requirements and Standard Operating procedures. This individual will act as main point of contact at site level, with internal and external stakeholders.

**Responsibilities**:

- Overall, conducts all types of study visits, ensures that site staff is trained on protocol and other study specific topics.
- Ensures quality on the site activities, through on-site off site visits, Conducts monitoring activities ensuring patients rights and safety is being protected. Ensures IMP is managed according to GXPs, regulatory requirements and Standard Operating procedures.
- 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 and recommends sites during the site feasibility and/or site selection process.
- Conducts pre-study visit as appropriate and reviews site activities and quality through on-site and off-site visits.
- While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions. Serves as a point of contact for Sites, provides trainings to sites.
- 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. Oversees activities of site personnel over whom there is no direct authority
- Anticipates, identifies and proactively supports site in resolving issues as they occur.

**Requirements**:

- Bachelors degree required in field of study within life sciences or equivalent
- Clinical Trial Monitor: 2-3 years of relevant clinical research experience, able to work in dependently
- Basic to good knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
- Knowledge and understanding of clinical research processes, regulations and methodology
- Understanding of the clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Organization and time management skills
- Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations
- Good verbal and written communication skills (both in English and Spanish)

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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