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Lead Global Clinical Trial Coordinator

2 months ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

Position Overview:
As a Lead Global Clinical Trial Coordinator, you will engage across diverse therapeutic domains and research phases, partnering with multidisciplinary global teams to manage the operational elements of international clinical research projects from protocol formulation to the completion of the clinical study report.

Key Responsibilities:
Serve as a Mentor and vital resource for team members within the Global Trial Specialist (GTS) group.
Act as a Subject Matter Expert (SME) for relevant systems and processes.
Contribute to the operational management of clinical trials at various stages, ensuring timely delivery, budget adherence, and high-quality outcomes in compliance with ICH/GCP and applicable Standard Operating Procedures (SOPs).

Provide assistance in managing study deliverables, including timelines, study plans, and documentation, through collaboration with both internal and external stakeholders.

  • Participate actively in cross-functional study teams.

Support the performance and quality oversight of Contract Research Organizations (CROs) and/or vendors.

Operational Execution:
Contribute to achieving corporate and study team objectives, successfully completing assigned tasks while prioritizing effectively with guidance.
Proactively manage multiple assignments and operational workflows with minimal supervision, having a significant functional impact on the study team and the organization.

Responsibilities will encompass a blend of execution and oversight, contingent on the sourcing model, to ensure deliverables, which may include but are not limited to:

  • Project Management:
    Provide operational insights and facilitate processes as an SME in support of study initiation, maintenance, and closure.
  • Utilize performance metrics and quality indicators to assist the Global Trial Manager in enhancing study execution.
  • Identify risks in collaboration with the study team and develop/implement strategies to mitigate potential issues.
  • Resolve routine challenges and escalate significant issues appropriately, maintaining a sense of urgency.
  • Actively contribute as a key functional member of cross-functional teams.

Study/Project Planning, Conduct, and Management:
Independently execute core GTS tasks and escalate or delegate when necessary.
Contribute during study meetings by providing updates related to GTS responsibilities and deliverables.

Support operational processes and management of study tools/plans throughout the lifecycle of studies, assisting the Global Trial Manager in driving study execution.

  • Exhibit flexibility to work on various trials of differing stages and complexities with minimal guidance.
  • Understand strategic decision-making at the program level and its implications for studies.
  • Contribute to initiatives aimed at process development and enhancement.
  • Assess situations and identify appropriate paths forward with the necessary resources.
  • Comprehend the interdependencies of assigned tasks.

Manage relevant attributes and milestones in the Clinical Trial Management System (CTMS).

  • Oversee the development and/or collection of necessary documentation, supporting the Global Trial Manager in ensuring the accuracy and completeness of the electronic Trial Master File (eTMF) for all studies.

Coordinate various meetings, including Investigator Meetings, Data Monitoring Committee Meetings, Study Steering Committee Meetings, and Kick-off Meetings, as applicable.

As necessary, manage the global setup of study-level non-clinical supplies and develop, update, and submit Transfer of Obligations to Regulatory Authorities.

Generate and manage reports and lists pertinent to assigned studies, overseeing study mail groups/distributions and SharePoint/Study Directory updates.

Participate in filing activities and any associated audits or audit responses.

  • Manage vendor relationships and site payment processing and tracking, as applicable.
  • Facilitate the maintenance of study budget tracking tools and reconcile invoices with overall contracts/budgets and financial reports, as applicable.
  • A Bachelor’s degree in a relevant discipline is strongly preferred.

If you encounter a role that piques your interest but does not perfectly align with your resume, we encourage you to consider applying.