FSPヘッド

Job Details

<職務内容>

・Manage approximately 60 CRAs
・Responsible for the supervision of assigned direct reports within Clinical Operations, FSPx and/ or Sub-CRO Services Staff
・Responsible for detailed performance review and management of assigned direct
reports including: Annual Performance Management and Development (PMD),
Individual Development Plan (IDP), Line of Sight Goals and “Shoves & Tugs”
・Responsible for appropriate management and resolution of performance issues
・Development and measure performance indicators for assigned staff
・Identify individual training needs and assist with the coordination and conduct of
training and development efforts, globally
・Recommend and coordinate appropriate training initiatives to ensure compliance with policies and procedures, globally
・Coordinate, conduct, report and follow-up on Quality Control Visits (CQC)
・Hold Cosource staff accountable for quality and compliance with client SOPs and
adherence to Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
・Coach assigned staff to own effective Investigator relations and Investigator oversight at the local level

<応募要件>

<Experience>
Required:
・Relevant clinical research experience in a pharmaceutical company or CRO
・Individual is proficient with on sited monitoring activities (including pre-study,
initiation, routine monitoring and closeout visits)
・Minimum of 9 years relevant clinical research experience in a
pharmaceutical company/CRO
・Through knowledge of drug development process
・Through knowledge of relevant SOPs, ICH, and GCP guidelines
Relevant supervisory experience:
・Minimum of 5 years as a Line Manager or Project Manager required
・Demonstrated ability to lead by example and encourage team members to seek
solutions
・Proven interpersonal skills
・Demonstrated ability to successfully participate as a member of a project team
・Demonstrated ability to successfully manage multiple competing priorities
・Advanced planning and organizational skills
・Advanced oral, written and presentation skills both in Japanese and English
<Education/Qualifications/Certifications and Licenses>
Required:
・University/college degree: life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
・In lieu of this required educational background the following relevant work history may be considered: Minimum of 7 years supervisory experience in a health care or clinical research setting and Minimum of 11 years relevant clinical research experience in a pharmaceutical company/CRO
Preferred:
・Masters or other advanced degree
<Travel Requirements>
・30% of travel by plane and car as required with overnight and domestic/potential international travel
・Ability to drive and have a valid driver’s license as appropriate per country travel norms
<Language Skills Required>
・Speaking: English and Local Language required
・Writing/Reading: English and Local Language required

※グローバルに展開するCRO、ライフサイエンス企業です。

※約90名のCRAが所属するチームのヘッドポジションになります!現在このグループは更に規模を拡大しております為、臨床開発でマネージング経験が豊富な方を募集しております。グローバルとのやり取りも多く、インターナショナルな環境でチームを牽引したいとお考えの方には非常に魅力的な案件になります。書類選考の後はカジュアルな電話面談となりますので、その際に企業やポジションについても理解を深めることが可能になります。ご興味がございましたら、是非お早めにお問い合わせください!

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company