Gsk
GlobalStudyManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Global Study Manager at Gsk. Deliver clinical operation activities from CSI to archiving. Generate robust and accelerated delivery plans”
What You'll Achieve.
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; Achieve overall study deliverables; Improve time and cost efficiency
Industry & Context.
Effective at problem solving and conflict resolution; Demonstrates conceptual, analytical and critical thinking; Balances riskenefit to make decisions based on clear understanding of impact on the study and project; Proactively and effectively identifies, oversees, and mitigates study risks
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.
Deliver clinical operation activities from CSI to archiving
Generate robust and accelerated delivery plans
Deliver plans to target or stretch thresholds with quality
Lead Operational Working Group for in-house studies
Accountable for operational delivery to time
Support decision-making at pace
Lead study team to achieve deliverables
Manage Study Initiation Meeting
Manage Clinical Study Activity Plan
Manage Study Delivery Plan
Manage TMF Quality Strategy Document
Manage Study Demographic and Diversity Plan
Manage Vendors Oversight Plan
Manage Results Dissemination Plan
Manage Investigator/CRA Meeting Set Up & training
Manage Expected Document List
Manage Recruitment Tracking
Manage Budget tracking
Manage Vendor Set Up and Management
Manage Patient Engagement Activities
Manage CSDD KOM & template
Manage Safety Management plan
Manage Protocol Deviation Management Plan
Manage eTMF & vendor set-up
Manage Pharmacy Manual
Support assessment and selection of FSO vendors
Oversee FSO vendors according to FSO handbook
Assess and select other study vendors
Ensure compliance with ICH/GCP guidelines
Understand study contribution to program/submission
Balance risk/benefit to make decisions
and mitigate study risks
Ensure appropriate stakeholder communication
Operate within the study budget
Lead empowered matrix teams
Implement innovative approaches to study delivery
Encourage others to seek innovative perspectives
Provide operational input into protocol development
Provide operational input into informed consent form development
Provide operational input into other key study documents
Lead investigator meetings
Lead other study related meetings
Lead quality efforts for protocol compliance
Lead inspection readiness for assigned studies
Ensure data quality plans are performed
Ensure end to end data cleaning is performed
Ensure Clinical Study Report is delivered on time
Support GSK’s adherence to local regulatory guidance
Oversee activities of participating countries
Provide support and coaching to SM
Increase utilization of AIML tools
Drive automation of manual processes
Find efficiencies and more effective ways of working
How You'll Work.
Team & Collaboration
Works in consultation with the Global Study Lead (GSL); Member of Central Study Team (CST); Leads the Operational Working Group (in-house studies only); Effectively leads empowered matrix teams; Able to lead and work within teams and networks across functional and geographical leads; Promotes collaboration, effective communication and leadership in others; Ensures appropriate stakeholder communication
Communication Scope
Excellent stakeholder management and communication skills (oral and written); Outstanding interpersonal skills; Ensures appropriate stakeholder communication
Process & Methodology
Generating robust and accelerated delivery plans, Delivering plans to target or stretch thresholds, Accountability for operational delivery to time, quality, and budget, Managing scope, budget, timeline, and resource planning, Managing competing priorities, performance targets and project initiatives, Risk management and contingency planning
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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