Bristol Myers Squibb Clinical Site Manager in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Responsible for phase I-IIIB clinical trial execution and oversight at the country and site level. Provides leadership and planning to ensure the effective and efficient delivery of the operational aspects of sites on assigned protocols. The STM has significant impact on delivering US specific study commitments and objectives while ensuring adherence to quality and timelines. Independently monitors the progress of assigned Investigative sites by maintaining close contact with site personnel and Site Monitors.
Coordinates and maintains effective communication (oral, written), and serves as primary BMS contact for sites.
Provides feedback and status updates to internal stakeholders. Independently manages activities at the site by providing guidance as required and by collaborating with other key stakeholders.
Documents substantive contacts concisely and in accordance with SOPs. Identifies potential site issue and suggests resolutions.
Demonstrates understanding of data management activities and ensures data currency for assigned sites.
Demonstrates a thorough understanding of all steps in the clinical research process.
Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy, and 5 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.
Experience executing Oncology Clinical Trials
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.