Lead Online

3 weeks ago

Mississauga ON, Canada GlaxoSmithKline Full time

Site Name: Canada - Ontario - Mississauga
Are 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.
As 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 management
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).
• 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. 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.
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Degree in scientific or business discipline
5 years of Data Management/Clinical experience (Pharma or CRO)
Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
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 Managers
Ability 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
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
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.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.
GSK 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. 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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