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PRINCIPAL CLINICAL RESEARCH SPECIALIST- SPECIALIST(Study Manager)

Medtronic
Tokyo
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PRINCIPAL CLINICAL RESEARCH SPECIALIST- SPECIALIST(Study Manager)

Location:

Tokyo, Japan

Requisition #:

20000I8K

Post Date:

Nov 06, 2020


**DEPARTMENT:RTG CLINICAL**


**REPORTING TO:MANAGER**


**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.

4. Select external suppliers

5. Clarify milestones and manage progress

6. Make contracts and fix them with sites

7. Gather data by EDC or paper CRF and manage them (Using CTMS)

8. Make budget plan with milestones, and manage them

9. Establish direction of analysis plans and pursuit of analysis

10. Build publication plans and publish outcomes if applicable

11. Make necessary reports to PMDA etc.

12. Prepare and succeed for audits and self check by internal audit team, external inspection body and PMDA as well as MHLW

13. Making reports to management and SBU if required


**Must Haves**


**REQUIREMENTS**


Knowledge/Education


+ Bachelor degree in science field

+ Knowledge of PML, PAL, GPSP ordinancesas well as J-GCP, Ethics guideline, relatednotices 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


1. Good communications skills with respect others

2. Making difficult decisions, including people issues

3. Logical thinking

4. Business Oriented (with Compliance and quality as primary focus)


**PREFERENCES**


+ PhD or Masters

+ MD or medical back ground and experiences


************************************************************************************


**About Medtronic**


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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.

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Posted: 2020-11-10 Expires: 2021-11-07
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PRINCIPAL CLINICAL RESEARCH SPECIALIST- SPECIALIST(Study Manager)

Medtronic
Tokyo

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