Senior Contracts Advisor - Queens University

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.

Review full job description, qualifications, and skills online.

Please apply online at:
https://clients.njoyn.com/CL4/xweb/xweb.asp?clid=74827&page=jobdetails&jobid=J1125-0292&BRID=EX430713&SBDID=21474&LANG=1.