Global Clinical Study Manager
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $116,300 - $156,300 per year
About the role
- Accountable for global study delivery with appropriate, inspection readiness quality, within agreed timelines and budget
- 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 that the clinical studies are operationally feasible, oversees trial feasibility, trial allocation and site selection process across all regions
- Provides oversight to study start up and site activation plans
- Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites
- Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members
Requirements
- Proven project management experience in global pediatric studies
- Oncology experience preferred
- Advanced knowledge of clinical operations methodologies
- In depth understanding of all aspects of clinical study processes
- Able to independently lead large and/or complex global clinical studies
- 5 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
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 operations methodologiesclinical study processesstudy timeline managementtrial feasibilitysite selectionstudy start upsite activationclinical study report preparation
Soft Skills
leadershipcollaborationcommunicationproblem resolutionstakeholder management