求人情報

2021-04-13

日本メドトロニック株式会社/PRINCIPAL CLINICAL RESEARCH SPECIALIST- SPECIALIST(Study Manager) – (20000I8K)

求人ID 17458
ネクストスリーより -
企業名 日本メドトロニック株式会社
雇用形態 正社員 
募集職種 PRINCIPAL CLINICAL RESEARCH SPECIALIST- SPECIALIST(Study Manager) - (20000I8K) 
職務内容 ◆Main Mission of Job
Pursue clinical trials, post marketing study and surveillance property effectively while aligning regulations and business needs. Collaborate with Global team, suppliers and external key stake holders such as Government, representative of hospitals and physicians.

◆Main Responsibilities
1.Develop strategies for trials, study and/or surveillance etc. plans and protocol
2.Negotiate with PMDA and/or physicians and other key stake holders of conditions and terms of trials, studies and surveillances etc. at the Shonin preparation phase and Shonin evaluation phase
3.Manage on going and new studies trials, studies and projects.
 ・Select external suppliers
 ・Clarify milestones and manage progress
 ・Make contracts and fix them with sites
 ・Gather data by EDC or paper CRF and manage them (Using CTMS)
 ・Make budget plan with milestones, and manage them
 ・Establish direction of analysis plans and pursuit of analysis
 ・Build publication plans and publish outcomes if applicable
4.Make necessary reports to PMDA etc.
5.Prepare and succeed for audits and self check by internal audit team, external inspection body and PMDA as well as MHLW
6.Making reports to management and SBU if required 
必須業務経験 ◆Must Haves
REQUIREMENTS

Knowledge/Education
・Bachelor degree in science field
・Knowledge of PML, PAL, GPSP ordinances as well as J-GCP, Ethics guideline, related notices and ISO14155
・Statistics
・MICROSOFT Exl, PPT, Word, Access
・English and Japanese : Business level

Job Experience
・More than 5 years of exposures of J-GCP/ISO14155 and GPSP
・More than 3 years of experience to manage external suppliers (CRO)
・Experience to set up EDC
・Project management
・More than 3 years successful people management experiences

Skills/Competency Required
ax.Good communications skills with respect others
ax.Making difficult decisions, including people issues
ax.Logical thinking
ax.Business Oriented (with Compliance and quality as primary focus)

PREFERENCES
・PhD or Masters
・MD or medical back ground and experiences 
年収 面談時にご確認ください 
資本金  
設立年月日 1975年11月 
所在地 東京都港区港南1-2-70 品川シーズンテラス 
業種 メディカル 
事業内容 メドトロニックは「人々の痛みをやわらげ、健康を回復し、生命を延ばす」ため、医療技術、治療法、サービスの提供を行っています。私たちはよりよい明日の実現を目指して、日々挑戦を続けています。メドトロニックは働く人にとって刺激的で、やりがいある仕事に満ちた職場です。
意義ある技術革新を生み出すため、私たちは強みである技術力をスピーディーに具現化することを目指しています。そのためには優秀な人材が不可欠です。メドトロニックは世界規模で起きている医療の課題に向き合い、患者さんの生活の改善に貢献します。
一緒に未来を築いていきましょう。 
求人の有効期限  
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