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

Medtronic Logo
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

GCP
SOP
Clinical Trials
Protocol Development
Patient Record Forms
Clinical Research
Trial Monitoring
Budget Management
Site Selection
Vendor Management

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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