Compliance Analyst

Description:

Queen’s University is hiring a Statistical & Computer Systems Compliance Analyst to support the Canadian Cancer Trials Group (CCTG). The successful candidate will play a vital role in ensuring the quality and regulatory compliance of computer systems used in research environments. This includes systems validation, risk assessment, policy development, and oversight of data security protocols.

Reporting to the Chief Information Officer (CIO), the analyst will be responsible for interpreting and applying regulations such as FDA 21 CFR Part 11, GCP, and GDPR to ensure that the CCTG’s computing infrastructure aligns with both internal and external compliance requirements. The role involves close collaboration with statisticians, IT teams, and regulatory bodies, requiring strong communication, critical thinking, and technical documentation skills.

This position provides an opportunity to engage in regulatory preparedness, audit support, system change control, risk mitigation, and development of IT documentation and SOPs in a mission-driven environment focused on cancer research.

Key Responsibilities:

• Validate computer systems and develop corresponding documentation and lifecycle plans.

• Perform risk assessments with respect to data integrity, audit trails, and access controls.

• Interpret applicable policies, guidelines, and standards to maintain IT system compliance.

• Develop and manage policies related to access control, change management, and validation.

• Support audit and inspection preparedness in collaboration with the CIO and statisticians.

• Coordinate system change controls and implement corrective action plans for audit findings.

• Provide insights on computing team data usage for projects led by other CCTG groups.

• Act as a liaison between the computing team and internal groups for specific IT projects.

Required Qualifications:

• University degree in statistics, computer science, MIS, or related discipline.

• At least 5 years of experience in statistical analysis and/or IT systems management.

• Strong knowledge of SAS, SQL, R, Python, Excel, and Tableau.

• Experience in database management is an asset.

• Understanding of system validation regulations (e.g., GCP, 21 CFR Part 11, GDPR).

Special Skills:

• Strong commitment to diversity, equity, and inclusion.

• Ability to write SOPs and technical documentation.

• Effective communicator and team collaborator.

• Strong organizational and analytical skills.

• Ability to manage competing priorities in fast-paced environments.

• High discretion in handling sensitive information.