Regional Clinical Trial Management (Senior) Associate

BeiGene 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:

About the Company:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across the United States, China, Europe and Asia Pacific region, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.

BeiGene 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.

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 (agenda, minutes, ..)
• 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 makes sure information is kept up to date
• Supports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region
• 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 (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters)
• 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 as per the study TMF QC plan
• 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 (eg, best practices and lessons learned, frequently asked questions) 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 incl PO set up
• Supports management of regional vendors incl 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
• 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)

Qualification Required:

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 as the benefit programs keep improving!

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.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative 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
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeiGene 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 BeiGene’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 BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.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) BeiGene’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) BeiGene’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.