Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D


Position Summary

The Manager, Clinical Data Management is responsible for overseeing the end to end Data Strategy & Management (DS&M) study related activities and is accountable for all Data Management study deliverables in terms of quality & delivery to plan. This role mentors other DS&M team member(s) and acts as Subject Matter Expert.

Responsibilities

• Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include: o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments

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

o Interim and final cleaned database lock

o Archival of all DM documents in the eTMF

o 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 standards to 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
  

Basic Qualification

• Bachelor’s Degree, in scientific or business discipline
• The individual in this role needs to be able to manage varied and multiple studies associated with the size and complexity of the clinical trial phases and Therapeutic areas. This requires a skilled, disciplined, organized and systematic approach as would be expected from individuals with this background

Minimum Level of Job-Related Experience Required

• Pharma and/or CRO experience.
• Understanding of disease area.
• Understanding of laboratory data.
• Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs

Preferred Qualification

• Experience working with global suppliers/ partnerships to ensure deliverables are to the agreed standard
• Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets• Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to facilitate data management activities, and the day-to-day running of a project or study-aligned team
• Supports capability build across the function
• Develops recommendations for study or project issue resolution• Builds influential networks within the organization & study team members. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goals
• Ensure sharing of knowledge and learning with the GSK Data Management Community• Assists in operational excellence and data quality focus negotiations with vendors and strategic partners
• Communicates technical topics to a non-technical audience.
• Uses an extensive network within GSK and external to keep abreast of industry trends and be part of the development of those trends
• Certification: CCDM (if present) added advantage

How to apply

If you want to grow your career while contributing to work that matters, please apply. We look forward to learning about your experience and how you would help improve clinical data quality and delivery.

Skills

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at [email protected] to discuss your needs.

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