Director or Associate Director, Clinical Start Up

BeiGene

Department: Clinical Operations

Report to: Executive Director, Clinical Operation

Direct Report/s: Start-up Managers

Purpose of Job:

Accountable for the study start-up timelines and delivery, with high quality and according to ICH/GCP

Major Responsibilities

  • Lead Startup team to the delivery of clinical start-up component of assigned studies with accountability for time, cost and quality for assigned activities, which include, but not limited to,
    • Investigator/Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study
    • Prepare IRB submission
    • Clinical trial site contract and budget negotiation, if required
    • Prepare, submit regulatory documents to HGRAC and obtain approval for required study
    • Assist CSM/ACSM in managing clinical trial during startup phase
  • Work closely with Clinical Operation leads to plan start-up resource
  • Contribute to strategy planning by bringing start-up expertise
  • Participate and assist in company Startup SOPs development
  • Establish and improve start-up work process at country level
  • Set up, maintain and update company-level investigator database
  • Establish, maintain and enhance relationship with key opinion investigators and sites
  • Provide ongoing mentoring and training to Start Up team members
  • Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside start-up team. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans
  • Line management of assigned start up team members
  • Perform other duties as assigned by management

Qualification

  • Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
  • Knowledgeable expert in the execution of clinical trials, expert understanding of GCP/ICH Guidelines and other applicable regulatory requirements
  • Eight or more years of clinical research experience in the Pharmaceutical or CRO industry
  • Recent start-up experience in China
  • Demonstrated strong project leadership skills and capable of training / mentoring others
  • Demonstrated experience working on a team across multiple functional areas
  • Excellent communication, relationship building and interpersonal skills
  • Excellent organizational skills and ability to prioritize multiple tasks
  • Self-motivation with the ability to work under pressure to meet deadlines
  • Fluent in English (writing and speaking)

To apply for this job email your details to hr@beigene.com

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