Clinical Operations Contracts and Budget Lead

Uniting science, technology and talent to get ahead of disease together

Position Summary

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.

Responsibilities

Contracts and Legal Management

• 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

Budget Development, Negotiation and Financial Oversight

• 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

Operational Delivery and Compliance

• 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

Stakeholder Collaboration and Leadership

• 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

Continuous Improvement and Innovation

• 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

Why You?

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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.

Preferred Qualifications
If you have the following characteristics, it would be a plus:

• 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.

Work model:

This role is hybrid with regular on-site presence in our Mississauga office expected 2-3 days per week.

What we value
We value people who are curious, accountable and collaborative. We promote inclusion and welcome different perspectives. You will find learning opportunities and practical support to grow your career. If you want to make a meaningful impact through work that supports patient-focused studies, we encourage you to apply.

How to apply
Please submit your CV and a short cover note explaining why this role matters to you and how your experience matches the position. We look forward to hearing from you.

#LI-Hybrid

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD117,000 to CAD167,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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