Sr Clinical Research Spec - Exempt

Careers That Change Lives

In this exciting role, you will have primary responsibility in the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release. You will lead study management duties and drive processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and internal requirements for clinical studies.

Work with the Clinical Management to satisfy applicable regulatory standards and internal requirements for clinical studies. Assumes project management responsibilities for selected studies and site management activities as needed.

This role utilizes a broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position provides work direction and strategic oversight of personnel supporting their trial.

Peripheral Vascular Health therapies are a critical part of the vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.

We seek out and hire a diverse workforce at every level:
We need fresh ideas and inclusive insights to continue to be an innovative industry leader — that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.

Location:

Remote within the U.S; preferred location(s):
Santa Rosa, CA / Northern California - Bay Area / Plymouth, MN

Ability to travel up to 25% (domestic and international).

Responsibilities may include the following and other duties may be assigned:

• Oversees, designs, plans, and develops clinical research studies for products that are under Clinical Investigation.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and interpret results of clinical investigations in preparation for new device or consumer application.
• Oversees and manages operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.
• Prepares and manages clinical trial budgets.
• Serves as liaison between program management and planning, study team, and leadership.
• Provides work direction to a cross-functional team which includes site managers, monitoring, safety, stats, and others.
• Reviews status of projects and budgets; manages schedules and prepares status reports.
• Responsible for clinical supply operations, site and vendor selection.
• Represents the company from a clinical research perspective within the country/region and also 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 & awareness.

• Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Develop, maintain, and continuously improve the project management process, guidelines, tools/templates, best practices, and overall implementation.

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