北京招聘

  

Purpose of Job

  

• 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
  
  

            

Major Responsibilities

  

• Participates in clinical trial scenario planning (estimates timeline and cost, requests internal resources)

  

• 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 required
  
  

                        

Qualification

  

• Bachelors degree or higher in a scientific or healthcare discipline preferred

• 5 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
  
  

                

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。