oracle - United States | 2024-12-16 10:37:45

We are seeking a highly detail-oriented and dedicated Senior Clinical Consultant to join our Blood Bank Validation team. This role is pivotal in ensuring the accuracy and reliability of our blood bank software, classified as a Class 2 medical device by the FDA. As a member of a 17-person remote team, you will work autonomously, contributing to critical validation processes that uphold the highest standards in medical software performance.

Key Responsibilities

• Blood Bank Validation:
  • Execute clinical validation processes for blood bank software to ensure compliance with FDA regulations.
  • Develop, maintain, and execute detailed test scripts using Excel to verify software functionality.
• Testing & Documentation:
  • Perform software testing by following precise, repetitive procedures to ensure accuracy.
  • Utilize Camtasia to capture and document testing processes and results.
• Team Collaboration:
  • Participate in daily scrum meetings to prioritize and select tasks.
  • Work collaboratively within a remote team environment, managing your workload autonomously without micromanagement.
• Feedback Management:
  • Provide and receive constructive feedback to continuously improve validation processes.
  • Engage in regular video reviews to assess adherence to testing protocols and identify areas for improvement.
• Process Improvement & Training:
  • Assist in training new team members, progressively introducing more complex tasks until full proficiency is achieved.
  • Contribute to the development of best practices and process enhancements within the team.

Qualifications

• Educational Background:
  • Bachelor’s degree in Medical Technology, Clinical Laboratory Science, or a related field.
• Experience:
  • Minimum of 5-8 years as a Clinical Lab Scientist or Medical Technologist, preferably with blood bank experience.
  • Proven expertise in clinical validation processes within a laboratory setting.
• Technical Skills:
  • Proficient in Microsoft Excel, including formulas and macros.
  • Experience with Camtasia or similar video recording software is a plus.
• Core Competencies:
  • Exceptional attention to detail and accuracy.
  • Ability to perform repetitive tasks with consistency.
  • Strong communication skills, especially in giving and receiving feedback.
  • High level of autonomy and self-motivation in a remote work environment.
• Additional Requirements:
  • Must be based in the United States.
  • U.S. citizenship required; sponsorship not available.
  • Ability to obtain security clearance for potential VA or DoD projects is preferred but not mandatory at the time of hiring.

 

Career Level - IC3

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