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Clinical Trial Operations Manager

2 months ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Transforming Patients' Lives through Science

Bristol-Myers Squibb Company is a leader in the pharmaceutical industry, dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced professional to join our team as a Manager, eCOA Management.

Job Summary

The Manager, eCOA Management will be responsible for the operationalization of eCOA instruments for clinical trials, ensuring timely delivery and issue resolution. This role will work closely with clinical study teams and vendors to meet study requirements, and will be responsible for reviewing and coordinating study-level eCOA process documents.

Key Responsibilities
  • Provide leadership for the operationalization of eCOA instruments for clinical trials
  • Work with eCOA vendors to ensure effective development and deployment of eCOA instruments
  • Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery
  • Review and coordinate study-level eCOA process documents with clinical study team members
  • Oversee eCOA development and testing activities, ensuring requirements are well-defined and met
  • Resolve eCOA issues during study conduct in collaboration with study team members and vendors
  • Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS
  • Manage work assignments to ensure timely delivery
  • Identify and resolve issues that may negatively impact delivery of work, seeking support from leadership as needed
Requirements
  • Bachelor's degree required
  • At least 4 years of relevant industry and clinical trial experience, including at least 3 years of specific experience with eCOA technologies, instruments, and end-to-end operationalization of eCOA
  • Good understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA operationalization in a global arena
  • Solid technical expertise in eCOA processes, instruments, and clinical data acquisition/integration
  • Knowledge of industry-leading tools and emerging technologies supporting eCOA
  • Good knowledge of GCP/ICH guidelines
  • Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles
  • Demonstrated partnership across collaborative forums
  • Ability to self-start, be solution-oriented, collaborate effectively with stakeholders, and be accountable for results
What We Offer

Bristol-Myers Squibb Company offers a competitive benefits package, including a wide variety of services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.

We strongly recommend that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.