求人情報

2021-04-13

日本メドトロニック株式会社/Clinical Research Spec – (210000GB)

求人ID 17442
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 Clinical Research Spec - (210000GB) 
職務内容 ◆POSITION DESCRIPTION:
The Clinical Safety Specialist will work with other members of the MCO Clinical Safety team
located around the world, Clinical Operations, Data Management, Quality Assurance and
Regulatory Affairs to manage death and adverse event reporting in compliance with applicable
regulatory standards and Medtronic internal requirements.

◆POSITION RESPONSIBILITIES:
Review and triaging clinical trial deaths and adverse events (AEs) including serious
adverse events (SAEs).
Conduct Case Management in the Clinical Safety Database.
Interacts with investigational sites and field monitors to obtain additional pertinent
information as indicated.
Works with the clinical project team to ensure consistency in the assessment, recording
and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device
deficiencies). .
Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely
reporting of AEs, SAEs and UADEs including expedited and annual reporting and other
documents as needed.
Ensures appropriate distribution and notification of SAEs and UADEs to appropriate
personnel, partners, and clinical centers for protocol(s).
Liaison for safety-related questions ( e.g., to study team, field support, monitors, and
study sites)
Write Clinical Safety plan for assigned protocol(s).
Assists with preparation of assigned section of safety reports for annual reports, clinical
study reports, investigator brochure updates, and other documents as required.
Collaborates with data management and other departments on the development of case
report forms, study specific safety reports, and other study specific forms.
Assists with the writing of safety sections of clinical protocols and may present safety
monitoring at investigator meetings.
Performs other duties as assigned. 
必須業務経験 ◆BASIC QUALIFICATIONS:
Good written, oral, and interpersonal communication skills including knowledge of medical
terminology.
Proficient with MS Office products, word processing, spreadsheets, etc.
High attention to detail and accuracy and ability to manage multiple tasks.
Good prioritization and organizational skills.
Excellent problem solving skills
Flexible and dependable.
Works effectively on cross-functional teams.
EDUCATION REQUIRED:Bachelor’s degree
YEARS OF EXPERIENCE
2+ yrs safety experience
SPECIALIZED KNOWLEDGE REQUIRED
Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for
clinical trials.
Fluent with medical terminology

◆DESIRED/PREFERRED QUALIFICATIONS (optional)
RN, PA, PharmD, RPh, PhD, MD, DO, or allied health professional including Biomedical
Engineer, Biomedical Scientist.
Thorough understanding of the general clinical research process with broad knowledge of
GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations

◆Qualifications
Must Have: Minimum Requirements
・Bachelors degree required
・Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience 
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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