Senior Clinical Research Specialist at Medtronic

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in a technical discipline
Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience
(Preferred) MD or PhD degree in biomedical sciences or other relevant technical disciplines
(Preferred) Experience with clinical trials, clinical/medical and/or scientific writing or publication at Medtronic
(Preferred) Neurovascular medical device or stroke therapeutic area experience

Responsibilities

Develop clinical strategy and author clinical documents including but not limited to clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, clinical risk benefit analyses, and clinical marketing materials
Collaborate with cross-functional teams, such as marketing, sales, clinical, R&D, HE&R, Quality, Compliance and Regulatory, and may represent clinical on core teams for new product development and/or product expansions
Develop and maintain strong scientific knowledge of the therapeutic area, disease state, and current competitive landscape, with the ability to effectively write key clinical deliverables/sections of regulatory submissions, including regulatory responses
Develop a deep understanding of clinical data: how to interpret and effectively communicate/present the data, summarizing complex results, and presenting them in a clear, concise, and scientifically accurate manner to a wide-range of audiences
Conduct thorough scientific literature reviews and clinical evidence mapping, manage the literature database and prepare literature reviews for external and internal stakeholders, or for regulatory submissions
Develop and lead the execution of publication strategies in collaboration with internal and external stakeholders (e.g., physician investigators, KOLs)
Participate in the periodic reviews of recent scientific publications/conference presentations relevant to the business, draft article summaries for distribution to key stakeholders
Plan, direct, and drive multiple business critical projects in parallel to completion on time with independence under limited supervision
For all documents: author drafts, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers

Skills

Key technologies and capabilities for this role

Clinical ResearchClinical StrategyClinical Study ProtocolsClinical Study ReportsClinical Evaluation PlansRegulatory SubmissionsClinical Data AnalysisCross-Functional CollaborationScientific WritingTherapeutic Area Knowledge

Questions & Answers

Common questions about this position

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

The role requires working a minimum of 4 days a week onsite to foster professional growth and cross-functional collaboration.

What are the key responsibilities of this role?

Responsibilities include developing clinical strategy, authoring clinical documents like study protocols and reports, collaborating with cross-functional teams, conducting literature reviews, and leading publication strategies.

What skills are required for the Senior Clinical Research Specialist position?

Key skills include leading clinical document development, strong scientific knowledge of therapeutic areas, ability to interpret and communicate clinical data, conducting literature reviews, and managing cross-functional projects with limited supervision.

What is the company culture like at Medtronic?

Medtronic emphasizes innovation, putting patients first, cross-functional collaboration, and in-person exchanges to support professional growth in a connected, compassionate environment.

What makes a strong candidate for this role?

A strong candidate should have experience leading clinical and regulatory document development, collaborating across functions like R&D and Regulatory, and independently driving complex projects while maintaining deep scientific knowledge.

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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