Gsk
GlobalStudyManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Global Study Manager at Gsk. Accountable for operational delivery of clinical study/studies to time, quality, and budget. Support decision-making at pace and lead study team”
What You'll Achieve.
aiming to positively impact the health of 2. 5 billion people by the end of the decade; accelerating significant assets that meet patients’ needs and have the highest probability of success; delivering the clinical operation activities of the study / studies from CSI (Commit to Study Initiation) until study archiving; generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality; achieve overall study deliverables; improve time and cost efficiency
Industry & Context.
Effective at problem solving and conflict resolution; Demonstrates conceptual, analytical and critical thinking
What They're Looking For.
Must Have
In-depth experience in clinical research: study management, monitoring, data management, skills and experience in project management and tools, performer / executor of operational tasks with 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, 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 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
What You'll Do.
Accountable for operational delivery of clinical study/studies to time
Support decision-making at pace and lead study team
Accountable for Study Initiation Meeting
Accountable for Clinical Study Activity Plan
Accountable for Study Delivery Plan
Accountable for TMF Quality Strategy Document
Accountable for DCT Set Up
Accountable for Study Demographic and Diversity Plan
Accountable for Vendors Oversight Plan
Accountable for Results Dissemination Plan
Accountable for Investigator/CRA Meeting Set Up & associated training
Accountable for Expected Document List
Accountable for Recruitment Tracking
Budget tracking eTMF filing and Vendor Set Up and Management
Patient Engagement Activities
Safety Management plan
Protocol Deviation Management Plan
Supports assessment and selection of FSO vendors
Accountable for holistic oversight of FSO vendors
Responsible for assessment and selection of other study vendors
Ensures compliance with ICH/GCP guidelines
all applicable laws and regulations
Understand study contribution to program/submission
Balances risk/benefit to make decisions
Proactively and effectively identifies
and mitigates study risks
Ensures appropriate stakeholder communication
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Implements innovative approaches to study delivery
Encourages others within matrix and line teams to seek innovative perspectives
Responsible for operational input into protocol and informed consent form development
Leads and conducts investigator meetings and other study related meetings
Leads quality efforts to ensure protocol compliance
Ensures data quality plans and end to end data cleaning is performed
Ensures Clinical Study Report is delivered on time
Supports GSK’s adherence to local regulatory guidance
Oversees the activities of the countries participating in the study
Provides support and coaching to the SM
Ambassadors in increasing utilisation of AIML tools
Driving automation of manual processes
Finding efficiencies and more effective ways of working
How You'll Work.
Team & Collaboration
Effectively leads empowered matrix teams; Able to lead and work within teams and networks across functional and geographical leads by example and promotes collaboration, effective communication and leadership in others
Communication Scope
Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
Process & Methodology
skills and experience in project management and tools, Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
Full Job Description
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](https://www.gsk.com/en-gb/innovation/) 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 (CST). 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 Deli
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