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About the Role

Supports the Global Clinical Study Manager in global study delivery, ensuring delegated components of clinical studies are executed to expected quality standards, within timelines and budget. Supports alignment of study goals with clinical operations goals and objectives. Supports study vendor management and other assigned study management activities.

Responsibilities

• Supports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings.
• Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally.
• Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager.
• Actively contributes to GSMA task force initiatives and cross functional projects within scope, supporting process improvement, standardization, and implementation activities.
• Creates and maintains study-level SharePoint and CST distribution lists.
• Sets up the study in the appropriate systems (e.g., eTMF, CTMS) and ensures study-level information is kept up to date.
• Ensures system access is granted and managed appropriately across the study life cycle, supports user account management for systems used in study.
• Supports the development of various study plans.
• May assist in the review of study-related documents as delegated by the Global Clinical Study Manager.
• Organizes study-specific investigator meetings under supervision of the Global Clinical Study Manager.
• Might support the creation and review of site feasibility assessments required for study participation.
• Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates.
• Prepares metrics and updates to key deliverables for management as per information available in relevant systems.
• Supports the preparation of a study newsletter and other correspondence related to the study conduct.
• Supports the TMF specialist with study-level TMF creation and, as required, maintains the study-level TMF, including regular review and QC of TMF documents as per the study TMF QC plan.
• Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies.
• Supports the overall data cleaning activities and contributes to the follow-up of outstanding information.
• Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report Quality.
• Supports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.
• Learns and shares best practices in clinical operations methodologies, systems and processes with an emphasis on quality and compliance.
• Suggest improvements to enhance efficiency and the quality of the work performed on assigned projects.
• Might support the development of global study tools, working instructions and SOPs.
• Supports selection and set-up of vendors for global outsourced activities.
• Supports study budget management activities with responsibility for PO setup and payment invoice tracking across all study lifecycles.
• Might mentor junior team members/onboarding of new hires.

Requirements

• 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.
• Proficiency in MS Office Suite, including Excel, PowerPoint, and Project etc.

Skills

• Clinical study delivery
• Study vendor management
• Cross-functional leadership
• Clinical Study Team (CST) meeting organization
• Stakeholder collaboration
• Regulatory and ICH-GCP guidelines interpretation
• Global clinical trials operations
• Process improvement
• Standardization
• SharePoint
• eTMF
• CTMS
• System access management
• Study plan development
• Study document review
• Investigator meeting organization
• Site feasibility assessment
• Deliverable tracking (screening, enrollment, samples, data flow, deviations)
• Metrics preparation
• Study newsletter preparation
• TMF management
• Study drug forecasting
• Data cleaning
• Risk identification
• Best practice sharing
• Budget management
• PO setup
• Invoice tracking
• Mentoring junior team members
• Onboarding new hires

Location

• Basel
• Beijing
• Cambridge, U.S.

Work Type

• Full-time

Experience Level

• 3+ years

Education Level

• Bachelor or higher degree in a scientific or healthcare discipline
• Higher degree preferred

Salary/Compensations

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant!)

Benefits

• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!

About the Company

• BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
• With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
• We are committed to radically improving access to medicines for far more patients who need them.
• Our growing global team of more than 10,000 colleagues spans five continents.
• Our Values: Patients First, Driving Excellence, Bold Ingenuity, Collaborative Spirit.

Equal Opportunity

• BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
• Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection.
• Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne.
• For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
• If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
• If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
• If you have any concern, please DO NOT provide any resume or other personal information to us.