Support efforts to define, adopt, and oversee compliance to processes and standards related to technology solution development, validation, and delivery.
Monitor, identify, and implement continuous process improvement across technology platforms impacting clinical research.
Provide expertise to ensure technology solution projects adhere to established standards and quality expectations including validation, access control, audit trail reviews, system reviews.
Supports activities to develop and perform assessments on technology solution projects which are low or medium regulatory risk systems to identify and mitigate risks and prevent quality concerns.
Support monitoring and maintenance of oversight for the selection and implementation of technology platforms for quality management in support of delivery of products and services.
Quality Management
- Executes assigned actions related to the corporate Quality Plan.
- Provides guidance to eQMS modules users.
- Reviews and approves technology change requests and CAPAs submitted by internal stakeholders.
- Supports team members responsible for authorizing or rejecting change requests from a technology quality and validation perspective.
- Liaises with internal stakeholders to facilitate the development/revision and review of QMS documents (SOPs, Work Instructions, Associated Documents) to support technology platforms, Root Cause Analysis/CAPAs and training materials as required.
- Provides guidance, as required, to internal stakeholders relating to the interpretation of standards and regulatory requirements related to technology platforms used in clinical research.
- Performs general and administrative tasks including accurate and timeline completion of timesheets and training.
Technology Solution Project Quality Oversight
- Assists in providing guidance, consultation, and overall expertise to project teams in support of clinical study and/or validation activities through the applicable lifecycle.
- Supports others in overseeing, monitoring compliance status and activities to ensure compliant state for a project, business area, or portfolio.
- Supports activities to identify requirements for key validation deliverables, including but not limited to validation planning, risk and impact assessments, summary/reporting and Electronic Records/Electronic Signature regulations (where applicable).
- For technology related Quality Issues (QIs), provide support to internal customers with QI management, with particular emphasis on appropriate description of the issue, accurate classification, oversight of root cause analysis and consultation on appropriateness of corrective and preventative actions.
Regulatory, Ethical Conduct and Audit Monitoring
- Supports audits (internal, site, vendor) and associated Corrective Action and Preventive Actions (CAPA’s).
- Assists team leads in providing quality and GxP regulatory advice for technologies including risk assessment(s) used in a trial or trial program (client account) clarifying customer quality expectation for technologies including for system design/delivery and its maintenance.
Qualifications
- The successful candidate will possess either an undergraduate degree with 1-3 years of related experience and ongoing training, or a College Diploma with 4-6 years of related experience and training.
- Entry/mid-level experience in computer technology, quality and compliance (including computer system validation) and clinical research is preferred.
- Analytical, critical thinking, problem solving and attention to detail skills required.
- Knowledge of ICH GCP and global regulations governing technology platforms in clinical research is required.
- Basic knowledge of continuous improvement methodologies.
- Excellent interpersonal, verbal, and written communication skills as well as business understanding.
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*Accommodations for applicants with disabilities are available upon request throughout the recruitment lifecycle
