Clinical Operations Contracts and Budget Lead

GSK•Mississauga, ON

20h•$117,000 - $167,000•Hybrid

About The Position

This role within GMASE plays a pivotal part in driving the contracting and budgetary activities for assigned clinical studies at the country level, ensuring efficient and compliant study start-up and execution. As a Contracts and Budget Lead (CBL), you'll take ownership of developing, negotiating, and managing site and supplier contracts and study budgets—ensuring alignment with timelines, quality standards, regulatory requirements, and financial targets. Collaborating closely with the Local Delivery Lead (LDL), global study teams, legal, procurement, and external partners (including CROs and investigators), you will contribute to the successful execution of clinical trials by providing strategic and operational expertise in contracts and financial management. This is a dynamic and impactful role designed for individuals who excel in negotiation, stakeholder engagement, and operational delivery. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: The CBL will act as the subject matter expert for contracts and budget management within clinical operations, with accountability for delivering study-level contracting and budgeting activities to time, quality, and compliance standards, while supporting efficient study start-up and delivery.

Requirements

Bachelor’s degree: life sciences or related discipline (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
In-depth experience in clinical research: contracts, budgets, site negotiations, forecasting
Experience with contracting and legal queries, providing guidance on SOP interpretation, dispute resolution, and risk identification
Strong skills and experience using excel workbooks
Understanding of global and clinical trials regulations and start-up processes
Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
Ability to think independently, analyze and solve problems systematically and creatively, and to take a risk-based approach.

Nice To Haves

Advanced degree or professional certification in finance, contracting, clinical research, or related field.
Experience working with contract research organizations (CROs), clinical sites and third-party vendors.
Knowledge of Canadian clinical research regulations and clinical trial financial processes.
Familiarity with clinical trial management systems, eTMF, or financial management tools.
Experience supporting audits, inspections or corrective actions related to contracts and finances.
Strong analytical skills and experience using Excel or financial analytics tools.

Responsibilities

Leads the coordination, negotiation, and execution of investigator and supplier contracts and amendments in accordance with GSK SOPs and local regulations
Owns the full contract lifecycle, including intake, drafting, version control, execution, tracking, and close-out using contract lifecycle management tools
Ensures all contractual documents align with approved templates and collaborates with legal and procurement to maintain and update master templates and agreements
Oversees execution of legal documents such as CDAs, MSA, CTA, and compensation clauses, ensuring compliance and completeness
Acts as the key point of contact for contracting and legal queries, providing guidance on SOP interpretation, dispute resolution, and risk identification
Leads country-level study budget development using benchmarking and historical data in collaboration with the Local Delivery Lead
Negotiates budgets with sites and suppliers to ensure fair market value, cost efficiency, and risk mitigation
Manages budget updates throughout the study lifecycle, including adjustments due to protocol amendments
Provides expertise in budget management systems, identifying cost variances and opportunities for cost avoidance
Supports budget forecasting and provides regular budget status updates to internal stakeholders
Ensures all contracting and budgeting activities are documented and filed appropriately in the TMF, maintaining inspection readiness
Ensures compliance with ICH/GCP guidelines, local regulations, and GSK standards across all activities
Proactively identifies risks related to contracts and budgets and escalates issues to management as appropriate
Coordinates with CROs and supports outsourced studies as required, ensuring alignment and oversight of contracting activities
Acts as an expert resource and trusted partner to study teams, investigators, suppliers, and internal stakeholders
Builds strong cross-functional relationships with legal, procurement, finance, and global/local study teams to ensure seamless delivery
Provides training, coaching, and mentorship on contracting and budgeting processes and best practices
Supports communication and coordination activities across local and global teams
Drives efficiency and consistency in contracting and budgeting processes through use of standard templates, tools, and best practices
Leverages digital and AI-enabled tools to improve data quality, efficiency, and decision-making in clinical operations
Identifies opportunities for innovation, process simplification, and cost optimization