Position SummaryThis 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 aContracts 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.ResponsibilitiesContracts and Legal ManagementLeads the coordination, negotiation, and execution of investigator and supplier contracts and amendments in accordance with GSK SOPs and local regulationsOwns the full contract lifecycle, including intake, drafting, version control, execution, tracking, and close-out using contract lifecycle management toolsEnsures all contractual documents align with approved templates and collaborates with legal and procurement to maintain and update master templates and agreementsOversees execution of legal documents such as CDAs, MSA, CTA, and compensation clauses, ensuring compliance and completenessActs as the key point of contact for contracting and legal queries, providing guidance on SOP interpretation, dispute resolution, and risk identificationBudget Development, Negotiation and Financial OversightLeads country-level study budget development using benchmarking and historical data in collaboration with the Local Delivery LeadNegotiates budgets with sites and suppliers to ensure fair market value, cost efficiency, and risk mitigationManages budget updates throughout the study lifecycle,



including adjustments due to protocol amendmentsProvides expertise in budget management systems, identifying cost variances and opportunities for cost avoidanceSupports budget forecasting and provides regular budget status updates to internal stakeholdersOperational Delivery and ComplianceEnsures all contracting and budgeting activities are documented and filed appropriately in the TMF, maintaining inspection readinessEnsures compliance with ICH-GCP guidelines, local regulations, and GSK standards across all activitiesProactively identifies risks related to contracts and budgets and escalates issues to management as appropriateCoordinates with CROs and supports outsourced studies as required, ensuring alignment and oversight of contracting activitiesStakeholder Collaboration and LeadershipActs as an expert resource and trusted partner to study teams, investigators, suppliers, and internal stakeholdersBuilds strong cross-functional relationships with legal, procurement, finance, and global/local study teams to ensure seamless deliveryProvides training, coaching, and mentorship on contracting and budgeting processes and best practicesSupports communication and coordination activities across local and global teamsContinuous Improvement and InnovationDrives efficiency and consistency in contracting and budgeting processes through use of standard templates, tools, and best practicesLeverages digital and AI-enabled tools to improve data quality, efficiency, and decision-making in clinical operationsIdentifies opportunities for innovation, process simplification, and cost optimizationBasic QualificationsBachelor’s degree in life sciences or related discipline (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent professional experienceSolid knowledge of ICH-GCP,



local regulations, and regulatory processesIn-depth experience in clinical research: contracts, budgets, site negotiations, forecastingExperience with contracting and legal queries, providing guidance on SOP interpretation, dispute resolution, and risk identificationStrong skills and experience using Excel workbooksUnderstanding of global and clinical trials regulations and start-up processesExcellent stakeholder management and communication skills, outstanding interpersonal skillsAbility to think independently, analyze and solve problems systematically and creatively, and take a risk-based approachPreferred QualificationsAdvanced degree or professional certification in finance, contracting, clinical research, or related fieldExperience working with contract research organizations (CROs), clinical sites and third-party vendorsKnowledge of Canadian clinical research regulations and clinical trial financial processesFamiliarity with clinical trial management systems, eTMF, or financial management toolsExperience supporting audits, inspections or corrective actions related to contracts and financesStrong analytical skills and experience using Excel or financial analytics toolsWork ModelThis role is hybrid with regular in office presence in our Mississauga office expected 2-3 days per week.Salary RangeIn compliance with Ontario's provincial pay transparency legislation, the annual compensation for this role is CAD117,000 to CAD167,000, determined based on experience, qualifications, and internal equity.Equal Opportunity StatementGSK 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.#J-18808-Ljbffr

📌 Clinical Operations Contracts And Budget Lead - C$117,000 - C$167,000 A Year (Winnipeg)
🏢 GSK
📍 Winnipeg