Clinical Trial Monitor

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Clinical Trial Monitor 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. Position responsibilities: * Identifies new potential Investigators, through ongoing collaborationswith 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 sitesduring 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. * 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. * May support coordination and ensure database lock timelines are met as required locally. Position requirements: * 2-3 years of relevant clinical research experience, able to work independently. * Bachelors or Master degree required. Field of study within life sciences or equivalent. Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred Experience in the drug discovery/development process. 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 b