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At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive environment, we can make an impact on a global scale.
Job Responsibility:
Accountable for the end-to-end DS&M study related activities in terms of quality & delivery to plan
Accountable for one or several complex 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 standards to increase consistency, efficiency & productivity
Acts as the first point of escalation for all DM study issues
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
Requirements:
Experience managing end-to-end DS&M study related activities in terms of quality & delivery
Experience managing complex studies (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies)
Ability to lead day-to-day DS&M operational study related activities and act as a member of the study core team
Experience conducting sponsor oversight of end-to-end FSP/FSO study related activities
Ability to provide DM operational input into study design, protocol, study planning, and study documents
Ability to provide reports, status updates, feedback and advice to key study stakeholders
Experience overseeing and providing input to the development of budgets forecasts for FSP and FSO contracts
Ability to create or review study level timelines for DM deliverables
Experience promoting the implementation of clinical data standards
Ability to act as the first point of escalation for all DM study issues
Ensuring DM study deliverables are in compliance with SOPs and regulatory guidelines
Ability to develop and maintain excellent professional relationships with study team and other key stakeholders
Ability to act as a mentor for junior members of the DS&M team
Ability to act as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections