Clinical Contracts Manager

Site Name: Canada - Ontario - Mississauga Posted Date: Jul 22 2022 JOB PURPOSE/KEY RESPONSIBILITIES: The Local Clinical Contracts Manager role is a key role within the Clinical Operations Department in Canada responsible for: Leading the complex process of budget development, negotiation and execution of clinical study agreements (CSAs) and Amendments, and development of strategic initiatives to improve productivity or efficiency of budget development and negotiation, contracts execution, and clinical financial processes. Advising and acting as expert resource to the Clinical Operations Leadership Team and the department with respect to clinical financial issues and serve as point of contact for legal affairs and procurement partners. Ensuring due diligence of third-party suppliers is complete, all contractual agreements are managed through their lifecycle as per GSK Policies and Procedures and local requirements, to proactively identify risk and to develop mitigation strategies against those risks. Key Accountabilities Budget and Financial: Manage the negotiation and execution of institutional and non-institutional investigator contracts and amendments, including Confidential Disclosure Agreements and compensation clause changes, and ensure that all negotiation of contractual terms and conditions are based on approved GSK master templates, recommending preparation of new templates as needed and ensuring compliance with GSK Policies and SOPs. Develop and oversee tracking systems related to contracts, CDA, compensation clauses, external costs Prepare study budget templates and associated documents for study budget review meetings (in conjunction with the local study team) Facilitate budget negotiations as required with sites consulting with the local study team as needed Interact with global and local study team on issues relating to study budget-development. Oversee study budget forecasts and budget to actual reconciliation to the local study team at required intervals Legal and Contractual: First point of contact for all Clinical Operations personnel for all legal issues and primary point of contact between Clinical Operations and Legal Affairs with respect to contractual revisions Risk Management, Compliance and Governance Supervise the site budget negotiation process with accountability for ensuring compliance with GSK SOPs and Policies Update and maintain tracking systems related to budgets, contracts, compensation clauses, and other items relevant to clinical finance Proactively identify areas of risk to senior staff and participate in the development of an action plan to mitigate risk Collaborative Partnerships and Relationship Management: Identify and proactively raise issues and concerns in a timely, open and appropriate manner and develop recommendations/facilitate resolution People Development and Oversight Develop training materials and actively train GSK staff in financial procedures/processes applicable to clinical research on an ongoing basis. SPECIALISED KNOWLEDGE: Bachelor’s degree or equivalent. Major course of study in Health-related sciences preferred 3-4 years or more experience within clinical development or related industry Knowledge and/or experience of costing for contracts is required Highly proficient in software applications (including Advanced skills in MS Excel, budget tool development and ability to write data extraction queries) and analytical methodology Ability to perform complex calculations and forecasting for clinical studies Critical thinking and problem solving Knowledge of clinical development processes and procedures relating to finance, pharmaceutical industry drivers and the clinical development business Self-starter with ability to work with limited oversight Excellent communication skills both verbal and written Ability to build and foster relationships with internal/external customers Highly developed networking skills and interpersonal skills Superior influencing, facilitation and negotiation skills Strong attention to detail Experience in developing, executing and managing contracts an asset *LI-GSK GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. 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 [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting. As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis. 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