Asset Data Management Quality Lead

1 month ago

Mississauga, Canada GSK Full time

**Site Name**: USA - Pennsylvania - Philadelphia, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage

**Posted Date**: Nov 1 2023

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 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

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, 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 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
- Provides inputs, status updates and feedback on study progress, risk managem

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