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Senior Global Study Management Associate
BeOne Medicines. Support the Global Clinical Study Manager in global study delivery and execution of delegated clinical study components within quality, timeline, and budget requirements .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical study management, vendor management, and compliance within the biotech, pharma, or CRO industry. Proficient in managing study deliverables, supporting global clinical operations, and maintaining study documentation and systems.
Highest-signal resume keywords
Clinical Research ExperienceVendor ManagementStudy PlanningRegulatory ComplianceMS Office Suite Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study OperationsStudy Budget ManagementData CleaningStudy Drug ForecastingETMF ManagementCTMS ManagementStudy Plan DevelopmentProtocol Deviation TrackingOperational Risk IdentificationQuality Control
Soft Skills
CollaborationMentoringProblem SolvingCommunicationProcess Improvement
Tools & Technologies
SharePointMS ExcelMS PowerPointMS ProjectETMF SystemsCTMS
Industry Keywords
BiotechPharmaCROICH-GCP GuidelinesClinical Operations Methodologies
About the role
Key responsibilities & impact- Support the Global Clinical Study Manager in global study delivery and execution of delegated clinical study components within quality, timeline, and budget requirements
- Support alignment of study goals with clinical operations objectives
- Support study vendor management and other assigned study management activities
- Support organization and logistics for cross-functional Clinical Study Team meetings
- Collaborate with the Global Clinical Study Manager, Regional Clinical Trial Management Associates, and global and regional stakeholders
- Contribute to task force initiatives, cross-functional projects, process improvement, standardization, and implementation activities
- Create and maintain study-level SharePoint sites and Clinical Study Team distribution lists
- Set up studies in eTMF, CTMS, and other systems and maintain study-level information
- Manage study system access and user accounts across the study lifecycle
- Support development and review of study plans and study-related documents
- Organize investigator meetings under supervision
- Support site feasibility assessments
- Track study deliverables including screening, enrollment, biological samples, images, data flow, and protocol deviations
- Prepare management metrics and updates on key deliverables
- Support study newsletters and study-conduct correspondence
- Support study-level TMF creation, maintenance, document review, and QC
- Support study drug forecasting and supply activities
- Support data cleaning and follow-up of outstanding information
- Support planning and execution of the Clinical Study Report
- Identify operational risks and issues and recommend solutions with the Global Clinical Study Manager
- Share best practices and suggest improvements to enhance efficiency and quality
- Support development of global study tools, work instructions, and SOPs
- Support vendor selection and setup for outsourced global activities
- Support study budget management, PO setup, and payment invoice tracking
- Potentially mentor junior team members and onboard new hires
Requirements
What you’ll need- Bachelor or higher degree in a scientific or healthcare discipline; higher degree preferred
- Exceptions might be made for candidates with relevant clinical operations experience
- 3 or more years of experience in clinical research within Biotech, Pharma or CRO industry
- Knowledge of clinical operations methodologies
- Understanding of operational aspects of clinical study processes
- Knowledge of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines
- Proficiency in MS Office Suite, including Excel, PowerPoint and Project
- Ability to support global clinical study management, vendor management, study planning, quality, compliance, and budget activities
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Limited travel might be required