Regional Clinical Trial Management (Senior) Associate

Regional Clinical Trial Management (Senior) Associate

About us

BeiGene 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, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

Job Description:

General Description:

• Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget.
• Applies knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager.
• Supports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager.
• Supports regional vendor management in addition to other regional study management activities.

Essential Functions of the job:

Regional Trial Support & Collaboration

• Acquires regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants.
• Knowledgeable of clinical research operations, including interpretation and implementation of regulations/ICH guidelines.
• Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings.
• Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globally.
• As required, supports CRAs with various activities such as monitoring visit preparations, TMF filing.

Timelines, Planning and Execution

• Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.
• Sets up the countries and sites in the region in the appropriate systems (e.g., eTMF, CTMS) and keeps information up to date.
• Supports system access requests for the region/country and ensures these are managed appropriately across the study life cycle.
• Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager.
• May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager.
• Supports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager.
• Supports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate.
• Supports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents.
• Helps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholders.
• Supports the data cleaning activities and contributes to the follow up of outstanding information for region/country.
• Prepares site newsletters and other correspondence related to clinical trial conduct in collaboration with the study team.
• Might assist in resolution of routine study questions from clinical trial sites.
• Might support the maintenance of information for region/country in relevant public registries (e.g., CT.gov).
• Supports the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study Report.

Quality

• Supports the identification of operational risks and works with the Regional 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 the emphasis on quality and compliance.
• Might support the preparation of sites for quality assurance audits and inspections.
• Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects.
• Supports the development of local/regional tools, working instructions and SOPs.

Budget

• Supports selection and set up of vendors for activities outsourced in region/country.
• Supports management of regional study budget including PO set up.
• Supports management of regional vendors including PO set up.

What we expect from the successful candidate:

• Bachelor’s Degree in a scientific or healthcare discipline required, Higher Degree preferred (exceptions might be made for candidates with relevant clinical operations experience).
• MS Office proficiency.
• Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes.
• 2 or more years of experience in clinical research within biotech, pharma or CRO industry.
• Limited travel might be required.
• Full working rights in Malaysia (Citizen or PR).

What we offer to our valued employees:

• Market competitive compensation package including performance-based annual bonus scheme.
• Company shares (generous welcome grant and performance-based annual equity plan).
• In-house and external learning and development opportunities.
• Fantastic benefits program as per the current policy including personal health insurance reimbursement, monthly reimbursement for mobile costs, annual medical check-up reimbursement, and more.

Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer:

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.