Program Leader, National Cancer Trials Network

5 months ago

Kingston, Canada Queen's University Full time

**About Queen's University**

Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.

Come work with us

**Job Summary**

Reporting to the Manager, Office of Clinical Trials Management, the incumbent will lead the Canadian Cancer Trials Group (CCTG) activities related to the National Cancer Trials Network, US (NCTN) at CCTG. The core responsibilities of the Program Lead include the development, implementation and evaluation of standard operating procedures to ensure compliance with NCTN Program Guidelines and oversight of core deliverables for CCTG participation in the NCTN program, ensuring timely activation, accrual and high quality conduct of trials within the NCTN portfolio.

**KEY RESPONSIBILITIES**:

- Lead the NCTN clinical trials program within CCTG, to ensure the program consistently meets the goals and requirements of the NCTN (US) program and the terms of the grant award.
- Develop and maintain an in depth knowledge of the NCTN program to ensure CCTG is compliant with the NCTN Program Guidelines and the Group’s associated priorities and processes to ensure all aspects of CCTG NCTN activities and trial conduct are successfully implemented, both internally and externally.
- Identify existing, new and emerging NCTN activities, assess Group wide implications with respect to compliance and resource; initiate and implement processes to ensure quality, consistency and compliance.
- Participate in NCTN committees (Accrual Core Team (ACT), Clinical Data Interchange Standards (CDISC)) representing CCTG perspectives.
- Develop, implement and maintain key Standard Operating Procedures (SOPs), Work Instructions, templates and reference documents and associated training materials to support staff in delivering NCTN trials and program activities, ensuring consistency with CCTG policies and procedures and meeting the NCTN (US) Program Guidelines. Oversee training and education of staff and external participants participating in NCTN trials.
- Develop and implement processes to increase quality and efficiency suitable for NCTN clinical trials including:

- Electronic Data Capture (EDC) and electronic Case Report Form (CRF) development.
- Management and processes for trial amendments.
- Conduct an assessment of barriers and enabling strategies for timely trial activations and accrual.
- Develop relevant metrics and where gaps are identified, propose strategies to address these.
- Act as Study Coordinator for assigned studies within the NCTN portfolio.
- Undertakes additional duties in support of the NCTN Program within CCTG.

**REQUIRED QUALIFICATIONS**:

- Master’s degree in Health Sciences or equivalent program of study.
- Minimum of 5 years’ experience in clinical trials management or related position.
- Knowledge of relevant program guidelines, CCTG SOPs and experience with external collaborations is considered an asset.
- Consideration may be given to an equivalent combination of education and experience.

**SPECIAL SKILLS**:

- Respects diversity and promotes inclusion in the workplace.
- Excellent communication skills both written and verbal.
- Leadership and mentoring skills.
- Excellent judgement and decision making.
- Ability to work collaboratively with a team and across functional groups, as well as having the ability to work independently.
- Exceptional attention to detail.
- Outstanding analytical, problem solving and organizational skills.
- Expertise in data management, analysis, and understanding of systems involved in clinical trials.
- Knowledge of the regulations and guidelines essential to clinical trial conduct.
- Effective project management skills to plan, implement, and evaluate projects and initiatives.
- Highly organized, self-motivated, and can work to deadlines.

**DECISION MAKING**:

- Write, review and oversee the implementation of standard operating procedures and work instructions with a focus on alignment with program guidelines and regulatory frameworks. Ensure appropriate processes are in followed including required approvals.
- Identify key initiatives within the NCTN for adoption within CCTG. Provide training and support to ensure consistency across the NCTN Program.
- Ensure effective communication across internal stakeholders as it relates to process changes.
- Identify risks related to program requirements and implementation and escalate as needed
- Provide recommendations on best alternatives to a given problem, identifying potential risks and benefits of each.

**Employment Equity and Accessibility Statement

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