Data Management Quality Lead

As Data Management Quality Lead you will be responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following

•Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include:

-Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments

- Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation

- Interim and final cleaned database lock

- Archival of all DM documents in the eTMF

- Archival of the study database and provision of clinical data to the study site

•Accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study(different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies)

•For an in-house study, leads the day to day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters

•For a study 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 and ensures training on the protocol to the FSP resources working on the study

•Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register

•Provides reports, status updates, feedback and advice to key study stakeholders on study progress.

•May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts.

•Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these

•Promotes the implementation of clinical data standard sto increase consistency, efficiency & productivity

•Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level

•Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines

•Develops and maintains excellent professional relationships with study team and other key stakeholders

•Acts as a mentor for junior members of the DS&M team

•Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections

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
• Pharma and/or CRO experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Broad understanding of the pharmaceutical industry and the clinical development process
• Ability to influence others
• Experience in working with global suppliers/partnerships to ensure deliverables are to the agreed standard
• Experience in operating in a global organization
• Project management skills
• Coaching skills
• Capabilities to build network
• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
• Understanding of the tools of the trade, such as standards.
• Excellent communication skills
• Ability to interact with study team members
• Ability to communicates technical topics to a non-technical audience.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

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