Cambridge, Massachusetts / Tech - Digital Trial Solutions / Full-Time

Senior Clinical Quality Assurance Manager

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Company Overview

ConcertAI’s mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. ConcertAI’s leading real-world evidence, AI technology and software-as-a-service solutions support healthcare decision-making across clinical research & development through commercialization. Top biopharma sponsors, clinical research organizations, healthcare providers and institutions rely on ConcertAI’s evidence-generation and digital transformation capabilities to advance precision medicine and medical innovation.

 

Role Summary

The Senior Clinical Quality Assurance Manager provides advanced quality assurance support ensuring services, process, facilities, reporting, investigations, audits, and/or systems are in compliance with quality assurance standards and regulations. The candidate will be responsible for assuring the accuracy and integrity of clinical research activities and compliance with U.S. Food and Drug Administration (FDA) regulations, the International Conference of Harmonization Good Clinical Practice (ICH GCP), and organizational standard operating procedures (SOPs) while at all times protecting the rights, safety and welfare of study volunteers within the ConcertAI network of participating clinical sites. The individual will provide key support to assigned projects, streamlining communication, maintaining systems, and managing documents & information across Sponsors, Sites, third party Vendors and Digital Clinical Trial studies assigned to him/her.

 

Responsibilities

 

Requirements

 

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn. 

 

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.