Clinical Quality Assurance Manager

Science 37 • Morrisville, NC

4d

About The Position

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research The Clinical Quality Assurance Manager will participate in continuous improvement of the quality system framework at Science 37 by executing the internal clinical quality audit plans, supporting the identification and remediation of identified trends, and also the client audit lifecycle. This position provides daily, quality oversight of the conduct of clinical trials at Science 37. This position reports to the Director, Clinical Quality Assurance.

Requirements

• Bachelor’s Degree in science, engineering or other related field required
• 5+ years of experience in clinical research, biotechnology or other GxP environment specializing in Clinical Quality; traditional site experience a plus, both traditional and virtual site experience a major plus
• Proven track record of cross functional collaboration
• Knowledge of cGXP regulations and current industry best practices
• Excellent written and oral communication skills
• Ability to meet deadlines in a fast-paced environment
• Excellent interpersonal skills and savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a range of interpersonal skills and approaches with ability to select a best-fit approach.
• Strong organizational skills – ability to adapt to a rapidly changing work environment and remain in control of various project and changing priorities.
• Strong creative problem-solving skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
• Ability to provide guidance and structure while encouraging innovation.
• Ability to communicate in English (both verbal and written)

Responsibilities

• Supporting the identification and implementation of continuous improvement opportunities and initiatives.
• Assisting with the development and refinement of SOPs governing clinical and quality operations.
• Leading and/or assisting in advancement of uses of Compliance Quest and/or other quality systems.
• Execute the internal clinical quality audit plans.
• Tracking and follow up on SOP compliance and Audit responses
• Supporting deviation and CAPA investigations and resolution.
• Participating in client audit preparation, hosting and follow-up, including support of the “staging room” as needed.
• Conducting and participating in internal audits of Science 37 cGXP Departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs).
• Remain abreast of current regulations and industry best practices in clinical trials.
• Participate in other Quality Organization projects and initiatives as required

What This Job Offers

• Job Type: Full-time
• Career Level: Manager