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    Regional Clinical Study Manager - Seoul, 대한민국. - BeiGene

    BeiGene
    BeiGene Seoul, 대한민국.

    1주 전

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    풀타임
    설명

    Job Description:

    General Description:

  • Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations' methodologies, organizational, project management and leadership capabilities
  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through to closeout to ensure both internal and external deliverables are on time and on budget working under the guidance and direction of the Clinical Program Lead.
  • Ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity
  • Works to ensure adherence to a standardized approach to clinical trial management
  • Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters
  • Ensures alignment of clinical project goals with Clinical Operations program objectives

    • Essential Functions of the job:

  • Participates in clinical trial scenario planning (estimates timeline and cost, request internal resource)
  • Works with Strategic resourcing team to select study vendors
  • Oversees study vendors to ensure quality and delivery
  • Oversees the development of and adherence to clinical trial project timelines
  • Ensures senior Clinical Operation staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Ensures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timely
  • Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites
  • Ensures site monitoring reports are accurate and reviewed on a regular basis
  • Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status
  • Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis
  • Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts
  • Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if require
  • Conducts Study Oversight Visit (SOV), if required
  • Ensures inspection readiness at any point in time throughout the study life cycle
  • Prepares team for quality assurance audits and inspections

    • Qualification Required:

    Education Required:

    Bachelors degree or higher in a scientific or healthcare discipline preferred

    Supervisory Responsibilities:

  • RCSM to oversee and mentor new RCSM, if required
  • Provides performance feedback on team members as required

    • Computer Skills: Efficient in Microsoft Word, Excel, and Outlook

    Other Qualifications:

  • Fluent in English
  • Excellent organizational skills and ability to prioritize and multi-task
  • 8 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
  • Management experience of CROs and other Vendors preferred
  • Therapeutic or medical knowledge preferred
  • Experience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
  • Exhibits a strong understanding of methodologies and approaches
  • Strong written and verbal communication skills

    • Travel: potential travel of up to 30%

    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.

    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

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