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 (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 8,000 colleagues across five continents.
Job Description• Conducts monitoring (pre study, initiation, routine monitoring and closeout visit), if require
• Conducts co monitoring visits, if required
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Attends onboarding--, disease indication and project specific training and general CRA training as required
• Documents monitoring activities appropriately following ICH GCP and BeiGene standards
• Conducts Quality Oversight Visits (QOV), as requested
• Completes monitoring visit/ QOV reports timely
• Assists with investigator/site identification
• Assists site to prepare Ethics Committee submissions
• Facilitates clinical trial site contract and budget negotiation
• Manages site queries and communications
• Assists in managing clinical trials, if required
• Establishes regular lines of communication with sites and COMs
• Provides protocol and related study training to assigned sites
• Evaluates the quality and integrity of site practices escalating quality issues as appropriate
• Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
• Performs additional task as assigned
Qualification Required:
• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English (writing and speaking)
What we offer to our valued employees:
Market competitive compensation package including performance-based annual bonus schemeCompany shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunitiesFantastic benefits program as per the current policy including;Health Insurance providedMedical Check-up, flu vaccine reimbursementHome-office setup allowanceMonthly reimbursement for home office expenses (i.e. internet, mobile..)Wellness benefits (Employee Assistance Program)Paid parental leaveAnnual leaveMarriage leave and allowance, condolence leave and allowanceAnd 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 Korea Y. H. is committed to treating all applicants fairly and equally. As a Disability Confident employer, we will work with applicants to make any reasonable adjustments.
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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityBeiGene 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 in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year 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.