Job Description

Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

The Clinical Affairs Manager (CAM) is a member of the cross functional team responsible for determining clinical strategy and will serve as the main point of contact regarding project timelines, updates, needs, and emerging issues. This role will be responsible for driving market advancement of the company’s products through the creation and communication of scientific information, clinical practice change, and the development and engagement of key opinion leader relationships. 

• Lead design, planning, development and monitoring of clinical projects and trials in support of the business strategy.
• Design, write, review, and approve clinical evaluation plans, reports, PMCF studies, and clinical investigation documents in accordance with the clinical evaluation process and applicable regulatory standards.
• Define the regulatory strategy for new or updated product offerings in conjunction with Regulatory Affairs
• Provide input into design risk management documents and post market health hazard evaluations.
• Manage and maintain paper and electronic clinical trial documentation according to applicable regulations.
• Ensure project start-up activities by facilitating processes in preparation of regulatory documents, ensuring timely IRB approvals for clinical trials.
• Generate clinically and scientifically sound, statistically analyzed data to confirm performance claims supporting regulatory submissions, ensuring that the product conforms to defined user needs and requirements.
• Communicate project progress and updates to cross functional partners, investigators, and other stakeholders.
• Develop and manage project budgets, tracking expenses and ensuring they stay within approved parameters.
• Negotiate and manage contracts with vendors involved in the trial.
• Manage CRO and vendors, ensuring stated objectives and deliverables are met.
• Prepare and present project status reports and other reports to senior management. 
• Prepare data outputs for written and verbal presentations of study data for symposia, scientific presentations, and regulatory submissions, as appropriate, in collaboration with Regulatory Affairs.
• Provide clinical compliance guidance to drive global initiatives.

• Bachelor of Science degree or Master’s degree in a related science.
• Minimum 3 years directly supporting clinical research in medical or scientific area.
• Demonstrated knowledge of FDA regulations, ICH GCP guidelines and ISO 14155.
• Certification through a professional organization such as ACRP or SOCRA.
• Working knowledge of anatomy, physiology, and medical terminology in Interventional Radiology, Vascular Surgery, Cardiology and/or Oncology.
• Working knowledge of global regulations and standards related to the conduct of medical device clinical studies, preferred.
• Working knowledge of Microsoft Project or project management software.
• Prior experience with medical device quality systems.
• Ability to anticipate the needs of a changing landscape while demonstrating a strong knowledge of good clinical practices, and all applicable U.S. regulations governing clinical research. 
• Ability to work in a fast-paced environment.
• Ability to analyze data, identify and trouble-shoot potential issues with clear communication to internal teams and key stakeholders.
• Travel required up to 40%

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