Clinical Site Manager

Clinical Dev

icon-location-marker Hopewell - NJ - US
Posted 32 days ago Full_time R1517762

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.

Summary

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 a BMS contact for the Investigator.  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 issues and suggests resolutions.  Demonstrates understanding of data management activities and performs clinical data review to monitor data quality and coordinate resolution of clinical discrepancies.  Skilled in the use of technology.  Demonstrates a thorough understanding of all steps in the clinical research process. 

Qualifications

Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy, and 5-7 years of clinically related or relevant experience. Oncology experience preferred.  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 Systems.

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.