Clinical Quality Assurance Manager
Quality Assurance /
We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.
What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.
We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.
The Clinical Quality Assurance Manager (Clinical QA Manager) will provide consultation in the interpretation of good clinical practice (GCP) regulations, guidelines, policies, and procedures. The Clinical QA Manager will plan, conduct, and report on independent audits of internal systems/ procedures and vendors. The QA Manager supports, maintains, and reviews QA systems, corporate training programs, and corrective action and preventative actions (CAPAs).
- Prepare, coordinate, and/or host client and/or regulatory audits
- Manage annual internal and vendor audit programs
- Conduct QA audits (internal systems and vendor)
- Collaborate in SOP writing and/or review
- Write, review, and track CAPAs
- Review & approve audit plans to ensure they are adequate and reflective of the needs identified from risk assessment strategies
- Support and/or provide management with quality metrics and updates
- Assess internal and external quality information inputs to quickly adjust QA activities or initiatives
- Identify and coordinate training within the QA department
- Advise, as needed, on quality assurance and compliance topics
- Lead and/or participate in identified QA initiatives and projects
- Strong knowledge of FDA, GCP, and ICH regulations, guidelines, and standards governing regulated clinical research required
- Working knowledge and understanding of drug development and global clinical regulatory environment
- Insightful, decisive, proactive, and solutions-oriented
- Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy
- Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders
- Proficiency in MS Office including Word, Excel, PowerPoint, Outlook, SharePoint, OneNote, and virtual meeting software
- Flexibility with shifting priorities
- Available to travel as needed
EDUCATION AND/OR EXPERIENCE:
- Bachelor’s degree in scientific or related discipline, or equivalent work experience
- Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA
- Direct experience with internal/external clinical systems and process audits
- Experience in QA audits of Clinical Investigators and Clinical Vendors
- Experience in development of SOPs
- Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook
- Excellent presentation skills
PERKS AND BENEFITS:
- Competitive pay
- Career growth
- Full medical, dental, and vision benefit packages
- Commuter benefits
- Legal benefits
- The best coworkers, if we do say so ourselves
ProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.