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キービジュアル キービジュアル
更新日 2018-09-07
掲載開始日 2018-09-06

Clinical Operations Senior Manager

  • ハイクラス
  • ★★★★ マネージャーレベル
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取扱い会社
人材紹介
Michael Page Japan
企業名 Full Service CRO and Regulatory Consulting Company
職種
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 * Act as a line manager for CRA and Lead CRAs and a leader for clinical operations in Japan, ensuring all studies are carried out effectively and efficiently

*

Manage partnership with investigative sites and vendors and negotiate budgeting, time-line and resource allocation


Description

* Coach, mentor, guide and train CRAs, CRO staff and contractors with processes and systems

* Ensure all necessary training's are provided to staff to support their job performance and knowledge

* Conduct performance reviews to foster growth and improvement of staff

* Communication with sites and collaboration for the conduct of clinical trials (as necessary)

* Identification of key risks and conduct risk/benefit analyses on an ongoing basis

* Negotiation with investigative site budgets, CRA costs and vendor selection

* Plan and conduct of investigator's meetings and any regulatory meetings as necessary

* Clinical trial progress ensuring GCP and J-GCP compliance for clinical trials, including taking direct lead for protocol implementation and working directly with clients, regulators, CROs and other vendors to ensure the successful execution of programs in Japan

* Site feasibility and selection process and consult with the sponsor on the final site list

* Assist in the strategic consulting on review of PMDA or other regulatory agencies' consultation documents


Profile

* Strong clinical monitoring experience and knowledge of the full clinical development cycle
* Leadership and ideally some line management experience


Job Offer

* Opportunity to develop line management experience as a leader of clinical operations
* Collaborate with emerging bio-techs to gain market approval for crucial new drugs in the Japanese market


Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について
(社風など)
* Full service CRO providing regulatory consulting, clinical trial and market launch services to biotech and pharma companies without operations in Japan
年収 経験と能力に基づく   
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Clinical Operations Senior Manager

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