BeOne Medicines

Global Clinical Study Manager – gCSM

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $118,600 - $158,600 per year

About the role

  • Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
  • Leads all aspects of assigned clinical study(ies)
  • Leads global cross-functional study team and acts as point of escalation for resolution of issues within assigned study(ies)
  • Ensures alignment of study goals with clinical operations and corporate goals and objectives
  • Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required
  • Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these
  • Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs

Requirements

  • Proven Project Management experience in Global Clinical Studies (Oncology experience preferred)
  • Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes
  • Able to independently lead global clinical studies
  • 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
  • Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred. *exceptions might be made for candidates with relevant clinical operations experience.
Benefits
  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Project ManagementClinical Study ProcessesStudy Timeline ManagementRegulatory SubmissionInspection ReadinessClinical Operations MethodologiesStudy Document ManagementCross-Functional Team LeadershipIssue Resolution
Soft Skills
CollaborationCommunicationLeadershipStakeholder ManagementProblem Solving