One shared journey moves us forward. Bristol-Myers Squibb is a BioPharma leader offering opportunities to learn and grow professionally, working alongside smart, talented colleagues who are committed to helping patients prevail over serious diseases. Our medicines help millions of people around the world in their fight against cancer, heart disease, HCV, and rheumatoid arthritis. Our commitment to patients’ unmet medical needs drives innovation and pride in our record of achievement and we are recognized as having one of the most innovative pipelines in the industry with launches in Oncology and Specialty products. Job Description:
The Clinical Trial Monitor role is a primary site facing role, responsible for building collaborative, long lasting relationships with our external partners. The Clinical Trial Monitor performs routine monitoring visits from study start up to study close out and is accountable for ensuring patient safety, GCP compliance, delivery of patient recruitment targets and data quality and integrity at clinical trial sites. Responsibilities:
- 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.