Job Description

Senior Contracts Advisor




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.


We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.


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Job Summary

Reporting to the Chief Operating Officer, and responsible to the Senior Management team, the Senior Contract Advisor (SCA) plays a critical role in supporting the clinical operations, legal, risk/insurance, and procurement activities at the CCTG. The SCA leads the end-to-end process of timely contract development, negotiation, execution, and compliance for high complexity research CCTG contracts across national and international studies. The SCA works closely with industry and academic partners, sites, investigators, external vendors, and legal counsel in partnership with Queen's University Research Legal Services (RLS) to ensure compliance with legal requirements and applicable regulations and guidelines.



The SCA is a key leader who provides expertise on emerging contractual issues, oversight to legal risk and insurance processes and supports CCTG procurement activities. The SCA is a central resource that provides support, training, and mentorship for other key CCTG staff. Additionally, the SCA is a key network touch point providing support to the CCTG network membership process and execution of Participating Centre Agreements (PCA). The SCA has a strong understanding of clinical trial processes, regulatory requirements, and contract law.

KEY RESPONSIBILITIES:

- Leads drafting, review, and coordination of all clinical trial agreements required for the conduct of national and international clinical trials in partnership with Senior Management team. Includes, but not limited to, high complexity clinical trial agreements, intergroup agreements, data and material sharing agreements, participating centre agreements, and vendor service agreements.


- Partners with Queen's University Research Legal Services (RLS) to ensure CCTG contracts and processes are aligned with expectations. Leads regular meetings with RLS to identify priorities and timelines for CCTG.


- Serves as the primary contact for all CCTG legal matters internally at CCTG and externally with stakeholders. Liaises between legal, clinical operations, finance, and external stakeholders to negotiate contracts. Ensures internal review and input on specific portions of contracts by specialized CCTG staff where required.


- Manages contracting processes, maintains databases and trackers, ensures timeliness and accuracy, and reports on metrics Senior Management at minimum biannually. Communicates real time to Senior Investigators/Trial Teams responsible to ensure trial contracts are executed and meet the needs of the trials in development or progress.


- Identifies risks in meeting timelines and deliverables as well as contractual clauses of concern, escalates appropriately, and assists in correction and resolution.


- Ensures contracts adhere to internal policies, ethical standards, and applicable regulations.


- Conducts research and develops briefing notes for Senior Management team to advise on emerging issues and contracts on request.


- Supports procurement activities including vendor and service contract execution in partnership with finance and other subject matter experts.


- Supports audits and inspections by providing documentation and contractual evidence as needed.


- Coordinates insurance policies for CCTG, including Master and Trial Specific coverage, with Queen's Office of Risk Management. Leads annual renewal process to ensure timely and accurate completion. Facilitates changes required during the year for new trials/projects.


- Coordinates CCTG membership requirements nationally including new memberships and renewals. Distributes membership package, disseminates information received for evaluation, executes the Participating Centre Agreement (PCA) or renewal, and confirms to roster when membership requirements are met.


- Develops and implements policies, standard operating procedures, work instructions, and tools to ensure compliance and quality of processes. Identifies opportunities for process improvement and establishes plans for implementation.


- Provides operational direction, expert advice and project management, including delegation of tasks for successful execution of contracts.


- Mentors junior contract staff and provide training on policy interpretation, institutional requirements, and best practices. Assesses and provides staff training to ensure compliance.


- Participates in initiatives addressing best practices in contracting in clinical trials on behalf of CCTG locally at Queen's University and nationally/internationally as applicable.


- Ensures a positive and productive working environment consistent with the mission, vision, and values of the CCTG and Queen's University's commitment to equity, diversity, inclusivity,


indigenization, and accessibility.

- Undertakes other duties and special projects as assigned.

REQUIRED QUALIFICATIONS:

- Bachelor's degree in business, life science, law, or a related field. Master's or legal training /


experience preferred.

- Minimum of 5 years of relevant experience in clinical research contracting or legal coordination in academic, industry, or CRO settings.


- Experience with systems and contract databases/tools (e.g., Oracle, PeopleSoft, TRAQ, acQuire, Ironclad, etc.) is an asset.


- Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:

- Respects diversity and promotes inclusion in the workplace.


- Demonstrated knowledge of clinical research contracts, regulatory frameworks, and contract


negotiation practices.

- High level organizational, administrative, project facilitation and management skills with the ability to meet deadlines in a collaborative and fast-paced client-oriented environment.


- Knowledge of applicable legislation, best practices, standards, policies and procedures within the specialized area of clinical research and contracts management.


- Interpersonal skills to work collaboratively with a wide variety of stakeholders in a fast-paced and dynamic work environment. Ability to network and interact, as well as facilitate effective partnerships with key groups and individuals


- Strength in exercising appropriate critical thinking abilities to proactively manage and/or mitigate known risks and identify new issues that could arise to ensure effective contract negotiations. Flexibility, initiative, and resourcefulness to develop creative ideas that provide solutions to arising challenges.


- Demonstrates initiative and able to work well in a team-oriented environment.


- Exceptional communication skills to interact with individuals at CCTG and within Queen's University (Financial Services, Human Resources, Research Legal Services, Office of the Vice-Principal (Research), Office of Risk and Safety Services, Strategic Procurement Services, etc.)


- Sensitivity and ability to manage highly confidential information.


- Investigative, research, analytical and problem-solving skills.


- Ability to show initiative, take ownership, and work effectively on diverse and complex issues and projects under time constraints.

DECISION MAKING:

- Determine how best to approach resolution of complex contract issues including when escalation to Chief Operating Officer, Senior Management, and/or Queen's RLS is required.


- Determine the type of level of information needed by Senior Management to support decision making when issues identified impact expected contractual clauses or operational requirements.


- Review clinical trial agreements, identify clauses that require further review, and make


recommendations on wording.

- In partnership with the Senior Management team, determine priorities to ensure timely contract review and execution.


- Lead interpretation and implementation of policies or analyze procedures and recommend changes or amendments as required.


- Determine required policies, standard operating procedures, and work processes for efficient and effective processes.


- Independent decisions are an integral part of daily duties.




Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queen's 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+ persons. In 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 hradmin@queensu.ca.

Skills

Reference

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