Bristol Myers Squibb Company

Clinical Trial Manager

Location
Princeton, NJ, United States
Posted
Sep 12, 2020
Ref
R1529374
Required Education
Bachelors Degree
Position Type
Full time
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.

Project manager for US Clinical Trial Management deliverables. Accountable for clinical trials execution, oversight at the country and site level and primary point of contact for the study. Engage with start-up teams in site selection activities, monitor conduct of clinical trials and manage the trial from study start through database lock/study closure according to SOPs, GCP and regulatory guidelines. Coordinates and maintains effective communication and serves as the primary BMS contact for the site. Provide leadership and planning support to ensure delivery of the operational aspects of sites on assigned protocols with overall accountability for resourcing, deliverables and productivity. Responsible for eTMF completion, coordination and development of CAPA, implementation of country audit level findings, coordination of database locks, preparation of country specific documents, and inspections readiness for assigned trials. Demonstrates a full understanding of data management activities, monitor data quality and coordinate resolution of discrepancies. Skilled in the use of technology. Demonstrates a thorough understanding of all steps in the clinical research process.

Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy, and a minimum of 4 years of clinically related or relevant experience. Thorough understanding of ICH/GCP guidelines and regulations as they relate to protocol/site management. Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met. Knowledge of the pharmaceutical industry and the pre-clinical, clinical, regulatory and commercial components. A detailed understanding of project planning and management methods.Knowledge of Data Management and Clinical Trial Management Systems. Skilled in the use of technology.

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.