Global Study Manager

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

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

This position within GCSD is accountable for delivering the clinical operation activities of the study / studies from CSI (Commit to Study Initiation) until study archiving.  This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality.  The GSM role works in consultation with the Global Study Lead (GSL) for end-to-end delivery of the clinical study.

The GSM leads the Operational Working Group (in-house studies only) and is member of Central Study Team.

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

• GSM will be the Working Group (WG) Lead for Clinical Operations with accountability for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision-making at pace and leading study team to achieve overall study deliverables

• As Operational WG Lead, GSM is accountable for the following deliverables (to be adjusted accordingly for the STOM FSO model):

  • Study Initiation Meeting​

  • Clinical Study Activity Plan ​

  • Study Delivery Plan​

  • TMF Quality Strategy Document ​

  • DCT Set Up​

  • Study Demographic and Diversity Plan ​

  • Vendors Oversight Plan​

  • Results Dissemination Plan ​

  • Investigator/CRA Meeting Set Up & associated training​

  • Expected Document List​

  • Recruitment Tracking​

  • Budget tracking eTMF filing and Vendor Set Up and Management​

  • Patient Engagement Activities​

  • CSDD KOM & template​

  • Safety Management plan​

  • Protocol Deviation Management Plan​

  • eTMF & vendor set-up​

  • Pharmacy Manual ​

Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working

• Supports assessment and selection of FSO vendors

• Accountable for holistic oversight of FSO vendors according to the FSO handbook

• Responsible for assessment and selection of other study vendors under GCSD responsibility in consultation with GSL 

• Ensures compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission

• Balances risk/benefit to make decisions based on clear understanding of impact on the study and project

• Proactively and effectively identifies, oversees, and mitigates study risks

• Ensures appropriate stakeholder communication, including study status, expectations, risks and issues

• Accountable to operate within the study budget

• Effectively leads empowered matrix teams

• Implements innovative approaches to study delivery through external facing advances in technology and sciences and encourages others within matrix and line teams to seek innovative perspectives and develop solutions. 

• Responsible for operational input into protocol and informed consent form development, and other key study documents.

• Leads and conducts investigator meetings and other study related meetings

• Leads quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies

• Ensures data quality plans and end to end data cleaning is performed instream by the responsible line functions

• Ensures Clinical Study Report is delivered on time and supports GSK’s adherence to local regulatory guidance

• Oversees the activities of the countries participating in the study

• Provides support and coaching (where appropriate) to the SM

• Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working

Why You?
Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

Education Requirements:

• Bachelor’s degree: life sciences or related discipline

  The role will require a good understanding of complex clinical development and regulatory processes.

• Strong skills and experience in project management and tools. In-depth knowledge of GCPs and ICH guidelines. At least 10+ years of relevant study management experience in a pharmaceutical/scientific environment.

Job Related Experience:

• In-depth experience in clinical research: study management, monitoring, data management

• Strong skills and experience in project management and tools

• Strong performer / executor of operational tasks with strong skills and experience in study delivery

• Experience of working across multiple types of study designs

• In depth knowledge of GCPs and ICH guidelines

• Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills. 

• Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

• Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs

• Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)

• Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others

• Able to manage competing priorities, performance targets and project initiatives in a global environment

• Operational expertise in risk management and contingency planning

• Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency

• Demonstrates conceptual, analytical and critical thinking

• Effective at problem solving and conflict resolution

• Ability to manage change and uncertainty

• Ability to delegate tasks

• Demonstrates experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams)

• Demonstrates versatility and ability to adapt to working across multiple TAs

• Ability to think independently, analyse and solve problems systematically and creatively, and to take a risk-based approach.

What we value
We look for people who are curious, accountable and collaborative. We support inclusion and welcome different perspectives. You will find learning opportunities and practical support to grow your career. If you enjoy clear, purposeful work that helps patients, we encourage you to apply.

How to apply
Please submit your CV and a short cover note describing why this role matters to you and how your skills match the position. We look forward to hearing from you.

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 IN.recruitment-adjustments@gsk.com to discuss your needs.

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