Clinical Research Spec(CRDN/APV)

Location:

Tokyo, Japan

Requisition #:

20000JSZ

Post Date:

Dec 01, 2020


Department: CRDN APV Clinical


Reporting to: Manager


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**Main purpose of job:**


Create and manage documents for the conduct of clinical trialsin accordance with GCP _._


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**Main job duties / responsibilities:**


1. Communicate effectively with colleagues fromotherdepartments to prevent GCP violations and ensureconsistencyacross all documents in accordance with GCP.

2. Create the clinical investigation plan, annex, attachments, and case report forms to initiate the clinical trial. In addition, create study instructionsheets, SOPs and guidance documents.

3. Create and manage shonin submission documents to PMDA afterstudy completion.

4. Handle import and return of study devices.


**JOB QUALIFICATION**


**REQUIREMENTS**


Knowledge/Education


+ B.A. degree+ Knowledge of GCP ordinances

+ Microsoft Exl, PPT, Word,

+ English and Japanese : Business level (TOEIC above 650


Job Experience


+ Clinical study of medical devices or pharmaceuticals

+ Operational exetucion in Back Offic


Skills/Competency Required


+ Problem Solving

+ Logical thinking

+ Analytical Skill

+ Good communications with respect others

+ Positive attitude


**PREFERENCES**


+ Master of Science Degree

+ Licenses (Nurse, MT, etc.)

+ Monitor experience

+ PMDA GCP confamative audit experinces
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.