Global Trial Specialist

Posted 25 days ago
Main Location
New York City, NY, United States
Open jobs

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.

RDG Global Protocol Specialist:  Focus on global project and program level responsibilities that may vary based upon study type and outsourcing status. Activities may include, but are not limited to:

  • Manage the execution and setup of Data Monitoring Committees and Study Steering Committees

  • Responsible for Investigator Meeting planning and execution

  • Manage country planning, protocol level attributes and milestones/drivers in Eclipse

  • Manage the development and/or collection of study level documentation, ensuring eTMF accuracy and completion for all studies

  • Manage study level documentation and set up within MyTrials/SIP

  • Develop, update and submit Transfer of Obligations to Regulatory Authorities

  • Manage the global setup of study level non-clinical supplies.

  • Manage global vendor site lists and resolve issues related to site lists

  • Manage study mail-groups/distributions and Sharepoint/Study Directory updates

  • Actively participate in study team meetings for assigned protocols

  • Drive process/system enhancements related to PS responsibilities/deliverables

  • Identify issues and risks, develop mitigations and escalate appropriately

  • Manage and comply with various quality and compliance systems

  • Participate in filing activities as applicable

NRDG (Above Market) Protocol Specialist: Focus on global projects and multi-country studies

  • Management of study start up process

    • Debarment, ePlan, Study Creation, Site Creation, Cost Plan Creation

    • Vendor Creation as needed

  • Eclipse Maintenance (M&D, cost plans , funds etc)

    • Fund creation for HEOR and applicable Ex-US studies

  • Management of eTMF, Invoice Trackers, & SharePoint support

  • Facilitation of global contracting, funds and payments in collaboration with respective stakeholders

    • Ensure payment processing and reconciliation

  • Manage trial documents and data for the PM/SMs within given TA/Functional Area

  • Facilitate and actively participate in BoW Review meetings (max of 2/3)

    • iStar report generation for ISRs, Meeting minutes etc

  • Direct management of HEOR and NCR – Non patient enrolling studies/projects

    • Nexus System

  • Cross-functional engagement with various stakeholders

    • Legal, Finance, Medical, GP, R&D

  • Generate / develop necessary metrics reports from various data sources

  • Issue Resolution and troubleshooting

Degree Requirements

BA or BS

Experience Requirements

1-3 years’ experience in Clinical Research or related work experience.  Knowledge of ICH/GCP Guidelines. Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.  Proficient in Microsoft Word, Excel and PowerPoint.

Key Competency Requirements

Effective oral and written communication skills, ability to influence cross-functionally, demonstration of leadership capabilities

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.

Mission
We're a community of women leveraging our connections into top companies to help underrepresented women get the roles they've always deserved. Simultaneously, we work to build truly inclusive hiring processes and environments where women can thrive and not just survive.
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Global Trial Specialist
Bristol Myers Squibb