Demo

Manager, Clinical Affairs

Venova Medical, Inc.
Los Gatos, CA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/17/2025

Manager of Clinical Affairs

Location : Los Gatos, CA

Company Overview : Venova Medical is at the forefront of innovation in the dialysis access space, committed to improving patient outcomes with groundbreaking medical technology. As we prepare to embark on critical stages of clinical research for a new product requiring PMA approval, we are seeking a seasoned Manager of Clinical Affairs to help lead our efforts in launching and executing pivotal clinical studies in the United States.

Position Summary : The Manager, Clinical Affairs is responsible for site management, management of the electronic trial master file along with day-to-day oversight of clinical study vendors, and central IRB services. This position works closely with the leads of the sub-functions of clinical affairs (i.e., clinical monitoring, clinical document management, clinical project management, etc.) to ensure studies are well executed.

Key Responsibilities :

  • Manage and serve as sponsor point of contact for assigned clinical sites and establish regular lines of communication.
  • Manage site monitoring visit activity and other key performance metrics
  • Manage vendors providing study services, central IRB services, and hosting the electronic TMF.
  • Collaborate and cooperate with other clinical affairs sub-functions to ensure alignment on interdependent activities.
  • Oversee day-to-day execution activities and report to function leadership any training needed to ensure activities are conducted in compliance with applicable company SOPs, expectations and pertinent regulations.
  • Conduct quality and inspection readiness checks for the activities of the assigned sites and ensure identified issues are resolved.
  • Compile performance updates for functional area leadership and may present updates to the management team.
  • Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
  • Other tasks and responsibilities as needed.

Qualifications :

  • Bachelor’s degree in Life Sciences, Medical Sciences, or related field; Master’s degree preferred.
  • Minimum of 10 years of experience in clinical operations, 3 years with medical device studies, with a strong preference for experience in dialysis access technologies and 2 years as a CRA / Monitor.
  • Proven track record of successfully managing Early Feasibility Studies (EFS) and pivotal clinical trials.
  • Extensive knowledge of FDA regulatory requirements and PMA approval processes including GCP's.
  • Strong leadership skills with the ability to manage and motivate teams.
  • Excellent communication, organizational, and analytical skills.
  • Why Join Venova Medical? At Venova Medical, you’ll be part of a dynamic team that values innovation and is dedicated to making a significant impact in the healthcare industry. We offer a competitive salary, comprehensive benefits, and the opportunity to be at the forefront of medical technology that can transform lives..

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