Global Study Management (Senior) Associate (Global CTA)

BeOneis 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, with administrative offices inBasel,Beijing, andCambridge,U.S.To learn more aboutBeOne, please visit www.beonemedicines.com and follow us onLinkedInandX(formerly known as Twitter).

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

Job Description

General Description:

Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget

Supports the alignment of study goals with clinical operations goals and objectivesunder direction of the Global Clinical Study Manager

Supports study vendor managementin addition to other study management activities assigned

Essential Functions of the Job:

Cross-Functional Leadership Support & Collaboration

- Supports the Global Clinical Study Manager with the organization and logisticsfor cross-functionalClinical StudyTeam (CST) meetings
- Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial ManagementAssociatesand other key stakeholders globally and regionally
- Knowledgeable of clinicalstudyoperations, including interpretation and implementationofregulatory and ICH-GCPguidelines
- 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 as required

Planning andExecution

- Creates andmaintainsstudy-levelSharePoint andCSTdistribution lists
- Sets up the study in theappropriate systemse.g.eTMF,CTMS etc and makes sure 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 ofvariousstudy plans




- May assist in the review of study-related documents as delegated by theGlobal Clinical Study Manager(e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
- Organizes study-specific investigator meetings under supervision of theGlobal Clinical Study Manager
- Might support the creationand review ofsite feasibility assessmentsrequiredfor study participation
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, dataflowand protocol deviationsin relevant systems in collaboration with Regional Clinical Trial Management Associates
- Prepares metrics and updates to key deliverables for managementas per information available in relevant systems
- Supports the preparation of a study newsletter and other correspondence related to the study conduct (e.g.frequentlyasked questions, lessons learned) in collaboration with the study team
- Supports the TMF specialist with study-level TMF creation and, asrequired,maintainsthe study-level TMF, including regular review and QC of TMF documents as per thestudy TMF QCplan
- 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 theGlobal Clinical Study Managerwith planning and execution of the Clinical Study Report

Quality

Supports the identification of operational risksand issuesand works with theGlobal Clinical Study Manager to recommend solutions for discussion with appropriate teamleadership

Learns and shares best practices in clinical operations methodologies,systemsand processes with an emphasis on quality and compliance

Suggestimprovements to enhanceefficiencyand the quality of the work performed on assigned projects

Might support the development of global study tools, working instructions and SOPs

Budget

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.

Supervisory Responsibilities:

Might mentor junior team members/onboarding of new hires

Qualification Required:

Education Required: Bachelor or higher degree in a scientific or healthcare discipline*, higher degree preferred.

Computer Skills:

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

Other Qualifications:

Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes

3 or more years of experience in clinical research within Biotech, Pharma or CRO industry

Travel:

Limited travel might be required

What We Offer To Our Valued Employees

- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

Join us and Make momentum in your career!

When we exhibit our values of Patients First, Team-oriented Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Acts Inclusively
- Demonstrates Initiative
- Results-OrientedAnalytical Thinking/Data Analysis
- Communicates with Clarity

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.

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📌 Global Study Management (Senior) Associate (Global CTA)
🏢 BeOne
📍 New South Wales