Principal Clinical Operations Manager

PhilipsFort Carson, CO
5d$122,906 - $231,840Hybrid

About The Position

Principal Clinical Operations Project Manager (Plymouth, MN local strongly preferred) The Principal Clinical Operations Manager leads the coordination and execution of clinical studies, collaborating with stakeholders to optimize operations and ensure regulatory compliance. This role manages complex negotiations, provides updates to senior management, and drives continuous improvement in clinical trial processes while maintaining alignment with Philips standards and timelines.

Requirements

  • You’ve acquired a minimum of 10 years leading clinical research trials with some experience leading medical device clinical trials. Knowledge and experience with peripheral vascular strongly preferred; cardiac or coronary experience and knowledge required.
  • Your skills include strong knowledge of all relevant regulations, standards, and guidelines (ISO, GCP, etc.). Familiarity with Cath Lab Operations is required.
  • You have a bachelor’s degree or higher in a related field. Will also consider nursing backgrounds with extensive clinical research experience in the cardiac space.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • You’re an expert level independent contributor who is able to multi-task a prioritize based on business needs, and take a proactive approach to drive efficiency in clinical research operations. You are willing and able to travel up to 25% as required by business needs.

Responsibilities

  • Leads and oversees all aspects of clinical study management, ensuring strict compliance with regulatory requirements (ISO, GCP, FDA) and Philips procedures, including site assessments, monitoring, training, and data integrity.
  • Serves as a subject matter expert and primary resource for study sites and investigators, providing guidance on protocol, regulatory standards, and best practices for clinical research involving medical devices.
  • Reviews and verifies study documentation, data, and deliverables for accuracy, completeness, and regulatory compliance, proactively addressing issues and discrepancies to maintain study quality.
  • Develops study plans and protocols, manages cross-functional relationships, and facilitates communication among internal departments and external collaborators to achieve project objectives and optimize study processes.
  • Monitors study progress, conducts data analysis, manages risks, and delivers timely updates and recommendations to senior management, ensuring alignment with budgets, schedules, and continuous improvement goals.

Benefits

  • Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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