Asset Data Management Quality Lead

1 week ago


Mississauga, Ontario, Canada GSK Full time

Site Name:
Canada - Ontario - Mississauga

Posted Date:
Apr


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.


Job Purpose

  • As Asset Lead Data Management Quality Lead you will be responsible for overseeing the endtoend 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_

Details
(_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, inhouse, 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 discipline_
  • 5 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 _
- _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. _
- _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 _
- _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 _
- _Pr

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