Job Posting | ConcertAI

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

Senior Clinical Quality Assurance Manager

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

Support audits and report preparation/distribution, Support quality issues management, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Vendor Audit plan development. Activities may include contacting auditees to agree on audit dates, making appropriate entries in the institutional system of record, filling out audit report forms, performing data reviews, file audits as directed
Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements
Conduct quality assurance audits of vendors delivering GXP services within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor
Enter and categorize audit/Inspection findings in internal system of record,
Solicit follow-up information and closing audits/inspection findings in the internal system of record,
Review vendor documents, identifying and calling vendor staff to answer related questions
Perform required administrative duties including tracking of documents reviewed, scheduling vendor team members for interviews
Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Assist in training of new Quality Assurance staff
Contribute to development of SOPs and best practices supporting our Clinical Center of Excellence.

Requirements

Bachelor’s degree education.
5-8+ years of quality assurance experience; level based upon experience
Expertise in interpretation of regulations, guidelines, policies, and procedures
Expertise in with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
Registered Quality Assurance Professionals in Good Clinical Practice (RQAP-GCP) designation preferred.
Demonstrates a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques
Oncology-specific experience is strongly preferred.
Highly proficient with MS Office, project management software.
Effective problem-solving skills with a demonstrated ability to identify and quickly resolve issues.
Excellent written and verbal communication and presentation.
Able to work successfully in a diverse team environment.

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.

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