シニア臨床試験スペシャリスト（モニター職） at Medtronic

Koto-ku, Tokyo, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Baccalaureate degree (or equivalent satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A)) with minimum of 4 years relevant experience, or advanced degree with minimum of 2 years relevant experience
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
Practical knowledge of project management

Responsibilities

Oversees, designs, plans, and develops clinical evaluation research studies
Prepares and authors protocols and patient record forms
Conducts registered and non-registered clinical studies of products that satisfy a medical need and/or offer commercial potential
Oversees and interprets results of clinical investigations in preparation for new drug, device, or consumer applications
Oversees and resolves operational aspects of clinical trials in conjunction with project teams, in accordance with SOP, GCP, and specific country regulations; may prepare clinical trial budgets
May be responsible for clinical supply operations, site, and vendor selection
Represents Medtronic from a clinical research perspective within the country/region and collects feedback from local customers and authorities
Builds and maintains optimal relationships and effective collaborations with various internal and external parties
Drives local evidence dissemination and awareness
Delivers and/or manages projects assigned, works with stakeholders to achieve results, and may act as a mentor or direct work of lower-level professionals
Works independently under limited supervision to determine and develop solutions; coaches and reviews work of lower-level specialists; may manage projects/processes
May be responsible for entire projects or processes within job area; contributes to work group objectives through building relationships and consensus
Makes improvements to processes, systems, or products to enhance performance; provides in-depth analysis and recommendations on process improvements
Communicates with senior internal and external customers and vendors; exchanges information to achieve objectives and influence decision-making
May provide guidance, coaching, and training to other employees; may manage projects requiring delegation and review of others' work

Skills

Key technologies and capabilities for this role

GCPSOPClinical TrialsProtocol DevelopmentPatient Record FormsClinical ResearchTrial MonitoringBudget ManagementSite SelectionVendor Management

Questions & Answers

Common questions about this position

What are the main responsibilities of this Senior Clinical Trial Specialist role?

Responsibilities include overseeing, designing, planning, and developing clinical evaluation research studies, preparing protocols and patient record forms, conducting clinical studies, interpreting results, and managing operational aspects of clinical trials in accordance with SOP, GCP, and regulations.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture or work environment look like at Medtronic?

Medtronic emphasizes a life-long career of exploration and innovation, leading with purpose to champion healthcare access and equity, while breaking down barriers to innovation in a connected, compassionate world.

What experience or skills make a strong candidate for this position?

Strong candidates are seasoned individual contributors who work independently under limited supervision, manage projects or processes, solve complex problems across multiple areas, communicate with senior stakeholders, and possess specialized knowledge from advanced education.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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