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 is 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
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
Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
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.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Bachelors or Master degree required. Field of study within life sciences or equivalent
2-3 years of relevant clinical research experience, able to work independently.
Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
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 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 local language).
Clinical Trial Management Systems (CTMS)
Electronic Data Capture Systems (eDC)
Electronic Trial Master File (eTMF)
Experience with Risk Based Monitoring methodology
Understands the drug development process, from early to late stage, including lifecycle management
Knowledgeable of scientific and medical principles which allow for understanding of concepts such as drug mechanism of action, drug interactions, safety concerns, disease and treatments of standard practice under study
Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
Understands Health Authority inspection and sponsor audit processes and is able to guide site and provide meaningful responses to findings when appropriate
Fluent in English (oral and written)
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to gender identity, race, color, religion, sexual orientation, national origin or disability.
We are proud of being recognized in Spain as a Top Employer company 2019 with certified excellence in employee conditions and also of being listed as one of the 100 best companies to work for in Spain in 2018 by Actualidad Económica magazine. Come, and join BMS now!
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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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