サイトマネジメント・ベンダーマネジメント - 製薬会社

勤務地 Tokyo, Japan
職種 正社員
給与 ¥10000000.00 - ¥15000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 臨床試験 / CRA / CRC,
お問合せ Eureka Teramura
参照 JO-2010-448991
about Eureka Teramura

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 「世界で最も革新的な企業」に選ばれる高い技術力を持ち、世界初の医薬品を数々開発しています
  • 希少疾患のための薬を手がけています
  • 働き方の整備に積極的です

[Responsibilities]
The Site Management Lead (SML) is accountable for overseeing outsourced (to CRO), FSP or in house CRAs (as applicable) including start up and monitoring activities to ensure the quality execution of protocol procedures, adherence to good clinical practices (GCP), evolving regulatory requirements and consistency of monitoring activities.

The SML is accountable for ensuring the CRO, FSP or in house CRAs monitoring study sites results in effective identification and problem solving of issues. Findings and solutions will be communicated to both our company and the CRO as applicable.

The SML supports the CRO staff, particularly CRAs as well as FSP or in house CRAs to understand complex protocol processes and procedures.

■Accountable For:

  • Act as company's point of contact for the site: develop and maintain productive relationships
  • Assessment of site monitoring activities undertaken by the CRO personnel, FSP and in house CRAs and any requisite escalation
  • Identifying any site and/or CRA performance issues, quality events or any other quality issues at the patient and/or site level

■Responsible For:

  • Proactively oversee start up processes to ensure expeditious start up of studies within geographical remit
  • Addresss protocol-related training gaps for FSP CRAs
  • Communicate clinical site assessment information to the Project Manager Country Operations (PMCO) and/or the CRA
  • Conduct Sponsor Oversight Site Visits (SOSV) to assess site and CRA performance
  • Maintain tools ot document and track clinical monitoring activities
  • Supporting inspection readiness activities at the site level, with geographical remit
  • Support implementation of CAPAs as necessary
  • CRA resourcing across allocated studies
  • Provide feedback to Internal and External Stakeholders as appropriate

[Requirements]

  • Extensive site management and monitoring experience across a range of highly complex disease areas
  • Demonstrated capability of effective monitoring and site oversight
  • Solid knowledge of clinical development processes with strong emphasis on monitoring
  • Ability to lead, troubleshoot and influence for quality and delivery
  • A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
  • Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
  • Experience in all study phases and in rare medical conditions preferred
  • Previous oversight and regulatory inspection experience preferred
  • Comprehensive and current regulatory knowledge, including GCPs
  • Experience conducting GCP or other training is a plus
  • Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 70% during busy periods)
  • Good organizational skills and ability to deal with competing priorities
  • Effective communication skills (written, verbal and presentation)
  • Creative thinker, curious and unafraid to ask questions
  • Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
  • Proficient with MS Office Suite (Excel, Word and PowerPoint).

[Employment Type]
Full time

[Salary]
10M-15M yen
※Experiences and skills will be considered

[Location]
Tokyo


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