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A Day in the Life

Clinical Study (Project) Manager (CSM) is responsible for managing and leading a clinical team to execute different types of clinical studies such as clinical trials and post market release studies, develop strategies for assigned clinical study considering business circumstances and regulatory requirements, and collaborate with not only internal team members including domestic/global study team, regulatory affairs department, but also external parties including suppliers, government agencies, medical staffs and physicians.

Background

The Clinical Research Medical Science Department (CRMS) is responsible for the evaluation/assessment of the safety and efficacy of new medical devices through domestic and global clinical research/trial and the submission to MHLW (PMDA) for the manufacturing and marketing approval. For the devices that obtain manufacturing and marketing approval, investigation/research is conducted to collect, detect, and confirm information on the quality, efficacy and safety of the medical device when used in general practice, these are information regarding the appropriate use and safety of the product which could not be collected during a clinical trial. Also, by conducting studies such as Post Market Release studies, new evidence are collected to investigate further clinical application for Medtronic products.

CRMS department in Medtronic is conducted by mainly 3 entities, Clinical Research, Clinical Solutions, and Evidence Solutions. Clinical Research covers all Pre-market projects, Clinical Solutions covers monitoring activities and safety reporting activities, and Evidence Solutions covers post-market projects.

Clinical Research Department consists of three divisions, the first to cover CRM/CAS, the second division to cover SH/CRDN/PVH, and the third to cover all MS/NS related medical devices, and is responsible to be the center of a project, communicating and cooperating with domestic/foreign counterparts and departments.

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Main responsibilities

1. In charge of the Clinical Study Manager (CSM) role as a primary contact of assigned clinical study

2. Develop a clinical study plan and create study execution documents.

3. Work closely with stakeholders including PMDA and/or investigators throughout all the phases of clinical study and negotiate study progress and study execution plans with them.

4. Management of ongoing/new clinical research/trial.

· Selecting external suppliers

· Clarifying milestone and managing the study progress

· Create and execute agreements with investigational sites and/or external suppliers.

· Contributing in data collection using EDC or paper CRFs and data management using internal systems

· Creating and overseeing milestone and budget planning/management

· Overseeing investigational device management

Secondary duties/responsibilities as applicable:

· Contributes in creating Statistical Analysis Plan and conducting the analysis according to plan.

· Participate in data publication planning, and publishing outcomes.

5. Overseeing PMDA reporting and responses.

6. Working with the internal audit team for internal audits

7. Work with external organization (such as PMDA office of conformity audit) for inspection,

8. Reporting, consulting and working with superiors and Operating Units (OU) as appropriate

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Job Qualifications

＊must have, +Nice to Have

Job Experience / Qualification

＊At least 5 years of work experience related to J-GCP/ISO14155, Ethical Guidelines for Medical and Health Research Involving Human Subjects, and Clinical trial Acts.

＊At least 3 years of experience managing external suppliers.

＊Project Management

＋Experience in the medical field (Nurse, Pharmacist, Technicians and etc.)

＋Work experience with Clinical Research or work requiring medical knowledge

＋Experience with PMDA GCP conformity inspection

＋CRA experience

＋Knowledge of medical devices and diseases

Knowledge

＊J-GCP/ISO14155

＊Ethical Guidelines for Medical and Health Research Involving Human Subjects, Clinical trial Acts and other related notifications

＋Statistical Analysis

＋Data Management

Skills

＊Excellent communication skills embracing diversity

＊Strong problem-solving skills and analytical skills.

＊Logical thinking skills

＊Business minded with compliance and quality-oriented

＊English：Business Level（TOEIC score around 800）

＊Japanese：Native Level

Education

＊Bachelor’s Degree

＋Doctorate or Master’s degree (Scientific field)

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here