Audit Group Team Leader

Audit Group Team Leader

About Queen's University

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Job Summary

Reporting to the Manager - Office of Audits, Inspections, and Partner Compliance, the Audit Group Team Leader will lead the Audit Team at the Canadian Cancer Trials Group (CCTG). The Team Leader will lead Audit Team staff to coordinate and implement audits of external participating clinical sites, external vendors and of internal processes to ensure compliance with applicable guidelines, regulations, standards and contractual requirements.

**Job Description**:

**KEY RESPONSIBILITIES**:

- Supervision of Audit Group team members (including auditors and associates) to ensure the team fulfills their responsibilities with regards to internal and external audit activities.
- Provides work direction, and technical/functional guidance to staff. Schedules and assigns work, and oversees its completion. Coordinates and monitors work flow.
- Schedules and approves, or recommends the approval of, employees’ hours of work, overtime and absences. Monitors and oversees employee attendance.
- Reviews assignments and provides feedback on work to employees. Provides input on work performance to management staff.
- Provides orientation and on-the-job training to employees in the unit. Provides coaching and feedback on work quality issues, providing related day-to-day supervision. Escalates unresolved performance and/or disciplinary matters to management.
- Manages and develops team capability and effectiveness by:

- Effectively motivating, monitoring and managing team/staff’s ongoing performance including formal appraisals.
Determining team training gaps, and developing individualized plans for identified needs, developing coaching/mentoring relationships.
Optimizing team function through priority setting, ensuring coverage, cross-training, and succession plans.
Facilitating team meetings and managing team conflicts so that problems are resolved constructively.
Ensure that each CCTG study, clinical site, and vendor is evaluated and audited as needed according to CCTG Standard Operating Procedures (SOPs) to ensure compliance.
- Create and maintain an audit planning and reporting database.
Regularly review quality metrics and implement appropriate audit activities (for cause, routine), as needed.
Allocate and track resources to ensure deliverables are met, and develop contingency plans.
Oversee the selection of experienced volunteer auditors and coordinate audits.
Develop and maintain close collaboration with other functional areas internally, and consult other team leaders, staff and stakeholders, including external collaborators.
- Develop communication processes regarding audit selection, conduct, reporting and resolution across internal offices and teams, external collaborators/vendors and clinical sites.
- Ensure compliance, documentation and confidentiality throughout all Audit Group actitivities. Ensure all audit processes, material and reports are fully compliant, secure, confidential and documented in SOPs and Work Instructions (WKIs) and regularly reviewed and updated. Ensure resolution of all significant audit findings and appropriate management of findings, including appropriate notifications are made.
- Travel to clinical sites and vendors to lead audits. May participate in interactions with industry or regulatory authorities with regards to audits or inspections.
- Undertakes additional duties in support of the Audit Group and the CCTG.

**REQUIRED QUALIFICATIONS**:

- Master’s degree in Health Sciences or equivalent program of study.
- Solid clinical trial conduct, auditing and monitoring experience including hands-on experience with several clinical trial components (e.g. monitoring, clinical study management, report writing, contracts).
- Minimum of 5 years relevant experience in one or more of the following: clinical research, clinical trial methodology, quality assurance in a healthcare setting.
- In-depth knowledge, strong understanding and experience of regulations and their implementation pertaining to clinical trials in Canada and other regions is required.
- Consideration may be given to an equivalent combination of education and experience.

**SPECIAL SKILLS**:

- Respects diversity and promotes equity and inclusion in the workplace.
- Team leadership and supervisory skills. Coaching and mentoring skills.
- Project management and leadership skills and experience.
- Outstanding analytical, problem solving and organizational skills.
- Excellent judgment and decision making skills in order to evaluate audit findings.
- Highly o