Senior Manager, Sponsor Oversight Lead

  • Contract
  • Japan



The Role:

The Sponsor Oversight Lead(SOL) supports for the planning, conducting and coordination of trial oversight activities together with internal and external stakeholders to ensure quality and integrity of the data.


You will be responsible for followings,

  • Develop the Sponsor oversight strategy together with the trial team
  • Plan and perform Sponsor oversight visits and booster/site oversight visits in Japan and APAC
  • Accountable for development of trial oversight plan and ensure regular review of the trial team’s oversight activities
  • Feasibility review
  • Support Regulatory Green Light activities
  • Drive eTMF spot-check for the trial team and in collaboration with the CTM and CTA
  • Oversight of CRO training records, monitoring report review etc.
  • Attend and coordinate CRA training activities with CRO
  • Support during inspections and audits


Moreover, you meet the following professional requirements:

  • It is expected that you have a minimum 5+ years’ experience with monitoring and/or co-monitoring of clinical trials (Oncology Phase I experience preferred)
  • Preferably 5+ years’ experience as Trial Manager from a CRO and/or pharmaceutical company
  • Extensive knowledge of working with trial oversight activities is required
  • HA inspection preparation and responding experience preferred
  • Ability to travel to field sites
  • Business level English (and native level Japanese, reading & writing)
  • Moreover, you meet the following personal requirements:
  • You are structured and process oriented
  • You have a quality mindset and able to prioritize your work in a fast paced and changing environment
  • You have good interpersonal and communication skills during interactions with investigators and other external and internal stakeholders
  • You are able to work independently as well as within global teams




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