ConcertAI is the leading provider of precision oncology solutions for biopharma and healthcare, leveraging the largest collection of research-grade Real-world Data and the only broadly deployed oncology-specific AI solutions. Our mission is to improve translational sciences; accelerate therapeutic clinical development; and provide new capabilities for post-approval studies to accelerate needed new medical innovations to patients and to improve patient outcomes.
ConcertAI has emerged as one of the highest growth technology companies in Real-world Data and AI, backed by industry leading private equity companies: SymphonyAI, Declaration Partners, Maverick Ventures, and Alliance|Bernstein.
- Conduct risk-based technology audits including, but not limited to, product development audits, Computerized System Validation and audits, system audits, supplier audits
- Provide support for regulatory inspections and sponsor audits
- Provide Quality representation on Serious Breach Assessments, Information Security Incidents and technology related policies and procedures
- Work independently and as part of the QA team
- Build a risk based internal audit and supplier audit plan
- Conduct on-site and/or remote audits, including delivering a written report within procedural time frames
- Facilitate sponsor audits/regulatory inspections, as assigned
- Working knowledge and expertise of ConcertAI policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed
- Proactively recognize areas for process/procedural improvements, providing input and take the initiative, as appropriate
- Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
- Mentor and assist with training of less experienced auditors
- Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested
- Be familiar with GxP required computer system validation requirements
- Maintain and/or develop records/documents for assigned areas
- Examine internal IT controls, evaluate the design and operational effectiveness, determine exposure to risk, and develop remediation strategies.
- Participate in the change management process.
- Communicate complex technical issues in simplified terms to the relevant staff.
- Review, evaluate, and test application controls.
- Travel on assignment, possibly up to 10%
- Other duties as assigned
- RWD knowledge, healthcare related experience in data integration for EMR/EHR, Payor & Provider systems and Pharma EDC systems
- Security guidelines surrounding HIPPA, HiTrust, SOCS2, GCP, PHI and GDPR
- Clear understanding of IT audit methodologies
- Excellent interpersonal, verbal, and written communication skills
- Excellent analytical skills
- Ability to manage multiple and varied tasks, and prioritize workload
- Accurate and detail oriented with excellent organizational skills
- Ability to execute strategy and plans
- High degree of flexibility and ability to adjust to changing priorities and unforeseen events
- Team leadership abilities and positive attitude
- Excellent knowledge of, and working experience with, regulations
- Excellent problem solving and negotiation skills
- Ability to work professionally with highly confidential information
- Ability to work independently and consistently in a fast-paced environment
- Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
- Experience with AWS and ability to learn internal computer systems
- A degree in information technology/computer information systems or related. (essential).
- Certified Information Systems Auditor (CISA) (essential).
- 2 years of work experience as an IT Auditor.
Learn More About ConcertAI
ConcertAI is transforming how healthcare is delivered and dedicated to improving patient outcomes in oncology by offering innovative solutions on how data and intelligence is used to solve healthcare problems. We are creating something special in our culture, by building a collaborative, engaged, patient focused, team approach to our mission. Our high-performance teams are looking to add great talent to the mix and we are hiring for the right mix of new skills and diverse mindset. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn.