Senior Contract Specialist, Clinical Research

Probity Medical Research Inc•Waterloo, ON

23h•CA$36 - CA$40•Hybrid

About The Position

Probity Medical Research (PMR) is seeking a Senior Contract Specialist, Clinical Research to join their team. This role is crucial for maintaining the legal and operational integrity of clinical research activities. The specialist will be responsible for reviewing, negotiating, and executing clinical trial and syndication agreements, identifying and mitigating contractual risks, and ensuring compliance with regulatory and business requirements. The position involves close collaboration with internal teams, sponsors, CROs, and legal stakeholders, serving as a primary contact for contract-related matters throughout the entire contract lifecycle. Additionally, the role will contribute to the development of standardized contract templates and the improvement of tracking processes to manage increasing study volumes. The ideal candidate will possess strong organizational skills, problem-solving abilities, and the capacity to manage multiple studies concurrently under strict deadlines, while also demonstrating discretion, critical thinking, and independent judgment. While remote work is an option, on-site presence may be required occasionally.

Requirements

A bachelor’s degree or college diploma in Law, Business Administration, Economics, or a related field
A minimum of 5 years of experience in contract management, legal administration, and clinical research contracts.
Ability to work independently with minimal supervision while collaborating effectively across departments.
Demonstrated experience independently managing complex contract negotiations from initiation through execution.
Strong understanding of contract interpretation, contractual risk assessment, and negotiation strategy.
Advanced Proficiency with Microsoft Office Suite Knowledge (particularly Word and Excel)
Experience with DocuSign and PDF editing software, and contract management systems.
Handle and prepare all aspects of confidential and sensitive documents
Demonstrated ability to manage multiple concurrent studies while consistently meeting deadlines.
Excellent analytical, problem-solving and decision-making skills.
Ability to exercise sound judgment while handling confidential and legally sensitive information.

Nice To Haves

Advanced Contract Negotiation
Contract Interpretation and Risk Assessment
Business and legal acumen
Advanced Critical Thinking Skills
Stakeholder Relationship Management
Conflict Resolution
Attention to Detail
Excellent Written and Verbal Communication Skills
Advanced Organizational and Time Management Skills
MS Office Proficiency
Creative and Innovative Thinking
Ability to work independently and be a team player
Task Delegation
Process Analysis
Adaptability and Flexibility
Collaboration and Teamwork
Advanced Problem-Solving and Analytical Skills
Strategic Decision Making
High level of professionalism and discretion

Responsibilities

Lead the review, negotiation, and finalization of complex Clinical Trial Agreements and Master Agreements and other research related contracts from draft through execution.
Independently manage high-value, high-risk, or strategically significant contract negotiations with sponsors, CROs and other external stakeholders.
Analyze sponsor-proposed contract language and develop negotiation strategies that balance legal, operational, financial, and business considerations.
Identify contractual, operational, legal, and financial risks, recommending appropriate revisions to protect the organization’s interests.
Resolve complex contractual issues by collaborating with internal stakeholders and external partners to achieve mutually acceptable terms.
Analyze sponsor-proposed contract language and develop negotiation strategies that balance regulatory, operational, financial, and business considerations.
Escalate significant contractual risks or unresolved legal issues to the Contracts Lead with recommended solutions.
Develop and update internal contract templates, language, clause libraries and negotiation guidance to ensure consistency, compliance, and efficiency in negotiations.
Recommend updates to templates based on regulatory changes, sponsor trends, operational experience, and organizational risk tolerance.
Promote consistency across negotiated agreements through standardized contract language and best practices.
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.
Support the Contracts Lead with workload planning, assignment coordination, and quality review activities where appropriate.
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.
Analyze contract metrics and recurring negotiation challenges to recommend operational improvements.
Support quality assurance initiatives by identifying trends, recurring issues, and opportunities for standardization.
Support departmental initiatives and special projects.
Perform other duties as assigned to contribute to the overall success of contract management processes.