Clinical Operations Manager

2 months ago


Cambridge, Massachusetts, United States Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a highly skilled Clinical Scientist to join our team. As a Clinical Scientist, you will be responsible for designing and executing clinical trial activities, working closely with clinical team members to execute activities associated with the conduct of clinical trials.

Key Responsibilities
  • Design and execute clinical trial activities, including protocol development, site management, and data management.
  • Collaborate with cross-functional study team members to ensure timely and effective execution of clinical trials.
  • Develop and maintain relationships with external partners, including key opinion leaders and contract research organizations.
  • Provide regular and timely updates to management as requested.
  • Develop and present clinical documents, including protocol and informed consent documents, to governance committees and development teams.
  • Conduct literature reviews and submit clinical documents to the Trial Master File.
  • Develop and present site and CRA training materials at Site Initiation Visits and Investigator Meetings.
  • Review clinical narratives and monitor clinical data for specific trends.
  • Develop Data Review Plans in collaboration with Data Management.
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
  • Submit clinical contributions to clinical study reports and regulatory documents.
Requirements
  • Master's degree in Life Sciences or related field.
  • 2+ years of experience in clinical science, clinical research, or equivalent.
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
  • Ability to understand assigned protocol(s) and their requirements.
  • Basic knowledge skills to support program-specific data review and trend identification.
  • Intermediate medical writing skills and medical terminology.
  • Basic planning/project management skills.
  • Detail-oriented with commitment to quality.
  • Basic knowledge of disease area, compound, current clinical landscape.
  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
  • Intermediate critical thinking and problem-solving skills.
  • Adaptable and flexible.
  • Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools.
Preferred Qualifications
  • Ph.D. in Life Sciences or related field.
  • Experience in clinical trials management, including protocol development, site management, and data management.
  • Knowledge of clinical data management systems and electronic data capture systems.
  • Experience with clinical trial software, including CTMS and EDC systems.
What We Offer

Bristol Myers Squibb offers a competitive salary and benefits package, including medical, dental, and vision care, as well as a 401(k) plan and stock options. We also offer a comprehensive training program and opportunities for professional growth and development.

Travel Requirements

This role requires domestic and international travel, up to 50% of the time.



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