Clincal Trial Manager I

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. ——Independently monitors the progress of assigned investigator sites by maintaining close contact with site personnel and internal project team. Coordinates and maintains effective communication (oral, written) and serves as a BMS contact for the investigator. Provides feedback and status updates to internal stakeholders on an ongoing basis. ——Demonstrates an understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project. Works closely with other study team members in the coordination of study activities to meet the appropriate timelines at the site/protocol level. ——Independently manages activities at the site and monitors study progress by providing guidance as required and by close collaboration with other key stakeholders (e.g. Medical Monitor, Protocol Manager, Clinical Trial Associates, Contract Administrators, Clinical Data Quality Managers and Site Monitor(s)) as applicable. ——Documents substantive contacts concisely and in accordance with SOPs. ——Identifies potential issues at the site or protocol level and suggests resolutions. Answers and resolves routine or site related questions independently. Knows when to defer difficult or unresolved issues to the appropriate team member. ——Independently disseminates information to appropriate BMS team members to ensure timelines are met (e.g. Site Manager(s), Clinical Data Quality Manager(s), Site Monitors, Clinical Trial Associate, Contract Administrators). ——Proactively identifies and resolves issues noted during site management which impact the overall protocol timelines and informs the appropriate BMS team members (e.g. Protocol Manager, Site Monitors, Line Manage) and coordinates follow-up. ——Ensures program level standards are applied at the protocol level from study start-up to data base lock. Shares experiences and best practices through coaching and feedback. ——Skilled in the use of technology. Is able to function independently in addition to coaching other team members. Effectively uses available tools and systems to gather information needed to manage site activities, generate reports and to provide feedback to the appropriate BMS team members (e.g. Site Monitor(s) , Line Managers, Hub Unit Manager, Protocol Manager and Medical Monitor). Communicates information and issues (globally or on a country level) to Site Monitors, Site Managers, Clinical Trial Associates, Clinical Data Quality Manager(s), Line Managers, Hub Unit Manager, and Protocol Manager to ensure that site management activities, protocol execution and study documentation are in compliance with study timelines, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or regulations. ——Demonstrates a thorough understanding of all steps in the clinical research process. Coordinates initial and ongoing training of Investigators, site personnel, vendors etc, and collaborates with other relevant internal stakeholder as necessary. ——Provides on-going training and mentoring to team members through a mentoring process using informal and/or formal presentations. Serves as a resource for colleagues. Understands how the issues of a single study can impact the overall project and contributes to establishment of best practices through coaching and feedback. ——Leads or participates as an active member of cross functional teams, task forces, or local and global initiatives 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.