Clinical Research Manager - Structural Heart

2+ years

Not Disclosed

Mountain View

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Manager (CRM) - Structural Heart & Aortic Operating Unit
Location: Primary: Mounds View, MN | Remote (U.S. Locations)
Travel: Up to 25% (domestic and international)

Company Overview:

At Medtronic, we are on a mission to alleviate pain, restore health, and extend life. As a global leader in healthcare technology, we are solving the world’s most challenging health problems with cutting-edge solutions. Join us and be part of an innovative team that is dedicated to improving healthcare access and equity for all. This role offers an opportunity to grow your career while contributing to the development of life-changing therapies in the Structural Heart & Aortic Operating Unit.

Position Overview:

As a Clinical Research Manager (CRM) in the Structural Heart & Aortic Operating Unit, you will lead a team of Clinical Research Specialists and oversee clinical research activities for key clinical programs, particularly in the Transcatheter Aortic Valve Replacement (TAVR) therapy area. You will report to the US Clinical Research Director and ensure the successful execution of clinical studies, providing leadership, strategic direction, and support for study management efforts.

This role requires a strong focus on people leadership, clinical trial oversight, and a deep understanding of regulatory requirements. You will manage resources, guide the team in executing clinical research programs, and work closely with cross-functional partners to enhance organizational performance.

Key Responsibilities:

Clinical Study Management:
Oversee the execution of clinical studies across local and global sites, ensuring compliance with regulatory requirements, ethical guidelines, and scientific validity. Manage the development of clinical evidence for pre-market trials and the entire product lifecycle.
People Leadership:
Lead, mentor, and develop the clinical research team, managing performance assessments, staff goals, and employee training. Provide guidance on site initiation, execution, and closeout activities. Foster a high-performance culture within the team.
Regulatory Strategy:
Collaborate with the regulatory team to develop strategies for timely product approvals, including preparing and revising the Investigational Plan (study protocols, CRFs, etc.), ensuring compliance with global regulatory bodies.
Budget and Cost Management:
Manage study and cost-center budgets, ensuring the clinical research projects are completed on time and within budget.
Cross-Functional Collaboration:
Interface with R&D, manufacturing, sales, marketing, and regulatory affairs to drive clinical-wide and cross-departmental initiatives. Represent the clinical team in internal and external audits.
Clinical Site Coordination:
Collaborate with study sites to ensure activities align with study needs. Maintain strong relationships with external parties, including investigators and CROs.
Post-Clinical Activities:
Assist in post-clinical activities, including product market launches and study result publications for medical literature and scientific meetings.

Qualifications:

Must Have (Minimum Requirements):

Bachelor’s degree required, with at least 5 years of experience in managing or leading clinical studies, preferably with people leadership/managerial experience.
Alternatively, an advanced degree (e.g., Masters, PhD, MD) with 3 years of clinical research management experience.

Nice to Have (Preferred Qualifications):

Advanced degree (Masters, PhD, or MD) in a technical field such as engineering, life sciences, or a related medical/scientific discipline.
Experience managing clinical trials within the cardiovascular or medical device industry.
Expertise in Good Clinical Practice (GCP) and regulatory guidelines for clinical trials.
Experience in clinical trial design, management, and strategy development across global studies.
Familiarity with cost-center management and budgeting.

Competencies:

Strong leadership and communication skills, with the ability to manage a high-performing team.
Proven ability to handle complex problem-solving and change management.
Global collaboration experience, particularly in cross-functional teams.
Ability to thrive in a fast-paced environment while maintaining a focus on quality and timely execution.

Physical Job Requirements:

While performing the duties of this job, employees are regularly required to:

Be independently mobile.
Interact with a computer and communicate with peers and co-workers.
Work in office or remote settings.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Benefits & Compensation:

Salary Range (U.S. Locations, Excluding Puerto Rico): $125,600 - $188,400 (base salary), with eligibility for Medtronic Incentive Plan (MIP).
Benefits Package: Medtronic offers competitive benefits, including health plans, 401(k), paid time off, and other incentives.
Work-life Balance: Flexible work options and a commitment to employee well-being.

For more details about Medtronic's benefits and compensation, click here.

About Medtronic:

We are engineers at heart, tackling the world’s most complex health challenges with a diverse, global team of 90,000+ passionate people. From research and development to manufacturing and marketing, we innovate to create life-changing solutions for people around the world.

Inclusion & Diversity: At Medtronic, we believe that diversity drives innovation. We foster a culture of inclusivity and work together to create meaningful solutions for patients, customers, and business partners.