Audit and Monitoring Group (AMG) Team Leader

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Job Summary

Reporting to the Manager Office of Compliance and Oversight (OCO) the Audit and Monitoring Group (AMG) Team Leader will lead one of the two teams in AMG namely the Canadian On-Site Monitoring Team OR the Residual and International Monitoring Teams. The AMG Team Leader will ensure AMG standard operating procedures are followed to ensure compliance with applicable guidelines regulations and standards. The incumbent will lead team staff to coordinate and implement monitoring and processes essential to the successful management of the respective clinical trials conducted by Canadian Cancer Trials Group (CCTG).

Job Description

KEY RESPONSIBILITIES:
Lead one of the two teams in AMG with respect to monitoring of clinical sites to ensure compliance with internal standards and national regulations including Good Clinical Practice (GCP). Ensure compliance with clinical trials guidelines and regulations and to ensure standards are met. Update team methods policies and train staff on changes affecting that team.
Manage and coordinate the program of monitoring visits that the team is responsible for to ensure the integrity of clinical data with respect to accuracy documentation methods or procedures and compliance with policies and regulations. Prepare and review monitoring reports. Report to the Manager OCO Compliance Director and the Clinical Trials Monitoring Branch (CTMB) as applicable. Liaise closely with key teams such as CTMB and Trial Teams.
Travel to cancer centres to perform on site monitoring visits. May participate in interactions with industry in regards to site compliance.
Coordinate the activities of the AMG team including assisting with training. Plan assign delegate work of the team and ensure work is carried out appropriately.
Provide work direction and technical/functional guidance to AMG team staff. Schedule and assign work and oversee its completion. Coordinate and monitor work flow.
Schedule and approve or recommend the approval of employees hours of work overtime
and absences. Monitor and oversee employee attendance.
Participate in screening and interviewing job candidates and providing input into staff selection.
Review assignments and provide feedback on work to employees. Provide input on work performance to management staff.
Provide orientation and on-the-job training to employees in the unit. Provide coaching and feedback on work quality issues providing related day-to-day supervision. Escalate unresolved performance and/or disciplinary matters to the Manager OCO.
Undertakes additional duties in support of the AMG team and the CCTG.

REQUIRED QUALIFICATIONS:
Masters degree in Health Sciences or equivalent program of study.
Previous relevant experience (minimum of 5 years) in one or more of the following: clinical research clinical trial methodology quality assurance in a healthcare setting.
Previous clinical trial monitoring experience including hands-on experience with several clinical trial components (e.g. monitoring clinical study management report writing contracts).
In-depth knowledge strong understanding and experience of regulations and their implementation (in particular ICH/GCP TCPS HC FDA CTEP OHRP) pertaining to clinical trials in Canada is required.
Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:
Respects diversity and promotes inclusion in the workplace.
Leadership and supervisory skills to motivate staff and create a positive work environment.
Ability to work collaboratively within a team and across functional groups as well as have the ability to work independently.
On-site monitoring/auditing experience or knowledge.
Knowledge of the purpose policies standards and procedures involved in monitoring clinical trials.
Interpersonal and communication skills (both verbal and written) to deal with a diverse group of individuals in a professional manner and ability to provide clear and accurate information.
Project management experience and strong analytical detail oriented and organized approach to work.
Ability to critically and accurately review and interpret medical information.
Ability to multi-task in a changing environment with the ability to prioritize workload.
Ability to problem-solve and exercise discretion. Must have the ability to adhere to strict confidentiality; ability to recognize and handle confidential information in an appropriate manner.
Must have influencing and negotiating skills.
Ability to make formal presentations and represent Group at professional meetings.
Computer skills including Word Excel PowerPoint knowledge of database structures (preferably Oracle and Medidata RAVE).
Ability to travel up to 40% time.

DECISION MAKING:
Determine effective communication processes (across teams departments centres etc.) and interface effectively with other AMG team members as well as Trial Teams CTMB and the Manager OCO to maintain GCP compliance.
Determine site visits required to ensure the integrity of clinical data and report to the OCO Manager.
In collaboration with senior leadership determine appropriate policies and procedures with respect to functions of the AMG Team and decide how modifications should be proposed and implemented.
Provide recommendations on best alternatives to a given problem identifying potential risks and benefits of each.
Assess the suitability of job candidates and recommend the most appropriate person for hire.
Determine priorities and make decisions about staff utilization and the assignment of work to achieve optimum efficiencies and productivity.
training needs and make recommendations for internal or external training to attain proficiency.
Monitor and assess output and the quality of employees work and recommend need for formal training or development plans to management and identify possible staff performance and/or disciplinary issues.

Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queens is strongly committed to employment equity diversity and inclusion in the workplace and encourages applications from Black racialized persons Indigenous people women persons with disabilities and 2SLGBTQI accordance with Canadian Immigration requirements priority will be given to those who are legally eligible to work in Canada.

The University provides support in its recruitment processes to all applicants who require accommodation due to a protected ground under the Ontario Human Rights Code including those with disabilities. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at .