Clinical Research Contracts Specialist - Waterloo
2 hours ago
Job description
Based in Waterloo, Ontario, Canada Probity Medical Research (PMR) is a Site Management Organization that partners with clinical research sites and pharmaceutical companies to provide essential services for clinical research trials. As a rapidly growing company, we are committed to advancing clinical research through exceptional service.
The Contract Specialist position plays a critical role in supporting the legal and operational integrity of clinical research activities by reviewing, negotiating, and executing clinical trial and syndication agreements. This role is responsible for identifying and mitigating contractual risks, ensuring alignment with regulatory and business requirements, and protecting the organization's interests through effective contract strategy and negotiation.
Working closely with internal teams, sponsors, CROs, and legal stakeholders, the Contract Specialist serves as a key point of contact for contract-related inquiries and supports the full contract lifecycle, including amendments, terminations, and document management. The role contributes to the development and maintenance of standardized contract templates and improves tracking processes to support growing study volumes.
As PMR continues to grow its partnerships with CROs, sponsors, and sites, this role supports increasing study volume by ensuring contracts are reviewed efficiently, consistently, and with appropriate risk awareness.
We thank all applicants for their interest, however, only those selected for further consideration will be contacted.
Job Responsibilities
Contract Management
- Review, negotiate, and finalize Clinical Trial Agreements and Master Agreements from draft to execution, ensuring compliance and favorable terms.
- Assess sponsor-proposed contract changes and determine whether to accept or propose counteroffers to mitigate risk and protect organizational interests.
- Conduct initial contract language reviews to identify and mitigate potential risks, ensuring alignment with regulatory and business requirements.
- Develop and update internal contract templates to ensure consistency, compliance, and efficiency in negotiations.
- Identify and implement improvements to the contract tracking process for both study and site agreements as contract volume increases.
- Manage assigned studies, maintaining accurate records to support operational efficiency and regulatory compliance.
Stakeholder Collaboration & Advisory Support
- Serve as a primary point of contact for internal and external stakeholders, addressing inquiries related to Clinical Trial Agreements and Syndication Agreements.
- Draft, execute, and maintain Syndication Agreements and related amendments, terminations, and supporting documents.
Additional Responsibilities
- Proactively reassess workloads to meet evolving study targets and strict deadlines.
- Perform other duties as assigned to contribute to the overall success of contract management processes.
Skills
- Contract review, negotiation & risk mitigation (Clinical Trial & Master Agreements)
- Strong understanding of contractual language, indemnification, liability & regulatory considerations
- Ability to assess sponsor-proposed changes and develop strategic counterproposals
- Template development & contract standardization
- Stakeholder advisory support (internal teams, sponsors, external partners)
- Contract lifecycle management & tracking process optimization
- Exceptional attention to detail and document accuracy
- Strong written and verbal communication skills
- Analytical thinking, sound judgment & confident decision-making
- Excellent organizational, prioritization & deadline management skills
- Independent work ethic with strong collaborative approach
- Adaptability in high-volume, deadline-driven environments
Qualifications and Requirements
- Bachelor's degree or college diploma in Law, Business Administration, Economics, or a related field
- A minimum 2+ years of contract management work experience
- Experience reviewing and negotiating Clinical Trial Agreements, Master Agreements, or related commercial contracts
- Experience working in clinical research or regulated environments considered an asset
- Science background or CCRP designation considered an asset
- Advanced proficiency in Microsoft Office Suite
- Experience using DocuSign and PDF editing software
- Demonstrated ability to manage multiple concurrent agreements and meet strict timelines
- Strong critical thinking, analytical reasoning & problem-solving capability
Working Conditions
This role is eligible for hybrid or remote work.
Monday-Friday 9:00AM-5:00PM
40 hours per week
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