Asset Data Management Quality Lead

Site Name: Canada - Ontario - MississaugaPosted Date: Apr 11 2024Are you an enthusiast Data Management Expert looking into Project Management experience? If so, this Asset Data Management Quality Lead opportunity could be an exciting opportunity to consider.Job PurposeAs Asset Lead Data Management Quality Lead you will be responsible for overseeing the end-to-end data management delivery for an asset and/or group of studies and will be accountable for all DS&M study deliverables in terms of quality & delivery to plan. The role manages stakeholders at the asset level, escalates risk appropriately and sets expectations with suppliers. This role mentor's other data managers, acts as a Subject Matter Expert and may include line managementDetails (Your Responsibilities):This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…Accountable for several studies in a clinical development program and has the ability and the seniority to manage the delivery of any study type, in-house, outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO). • Conducts & documents sponsor oversight of the end-to-end FSP/FSO study related activities. • Represents DM at the Asset level, providing status updates, feedback, and advice to key stakeholders on progress. • Provides DM input into the study design, the protocol, study planning, study documents including the study risk register and monitoring plan in line with value driven data cleaning principles. • Develops and maintains excellent professional relations with the asset and/or study teams and other key stakeholders. • Acts as the first point of escalation for all asset level DM issues and risks. Understands, mediates, and solves issues related to DM deliverables and escalates as required to DM representative on DS&M LT. • Manages vendor performance and ensures DM deliverables are following GSK SOPs (Standard Operating Procedure) and regulatory guidelines. • Oversees and provides input to the development of budgets and resource forecasts for FSP and FSO contracts. • Acts as a Subject Matter Expert, mentors, and coaches more junior members of the team. • Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity. • Leads the implementation of new processes, provide input on associated written standards & trainings, vendor quality assessments, audits, and inspections. • Engages externally to keep abreast of industry trends in data management. • May recruit and develop Data Management staff including objective setting, development feedback, coaching and conduct regular performance reviews. Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor's Degree in scientific or business discipline5 years of Data Management/Clinical experience (Pharma or CRO)3 years of Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard Preferred Qualifications:If you have the following characteristics, it would be a plus:Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to manage data management activities, and the day-to-day running of a study or project-aligned team Develops and implements new data collection strategies and therapy area standards Develops recommendations for study (or project) issue resolution Builds influential networks within the organization. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goals Influences key study or project team members or roles to meet the overall goal Gains buy-in from the Clinical Sciences Lead (CSL), Study Delivery Lead (SDL), Statistician, Clinical Programmer (CP) and other study team colleagues for data management agreements Works within a global network within the GSK Data Management community to ensure knowledge sharing and learning from the collective experience Communicates technical topics to a non-technical audience. Uses a network within GSK and external to keep abreast of industry trends and apply on studies in scope Experience mentoring other Data ManagersAbility to anticipate, identify and address technical and operational risks & issues at department level regarding delivery and quality Recommends, applies, and judges the impact of solutions within and across functions with a compliance focused and well-defined yet flexible approach Leverages learnings and coaches best practices across the department Ability to expertly listen, objectively challenge and influence key stakeholders and decisions Communicates proposals on leveraging the learnings (success or failure) after study execution to implement Coaches on improvements for the future Provides inputs, status updates and feedback on study progress, risk management plans, written standards & trainings, vendor quality assessments, audits and inspections to internal key stakeholders and external partners Engages externally to keep abreast of industry trends in data management Why GSK?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.#LI-GSKWhy Us?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.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 canada-recruitment@gsk.com.Please do not send resumes to this e-mail and instead apply through the online application process of this posting.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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