GSK · 1 day ago
Global Study Manager
Collegeville, PA
Full-time
Hybrid
Senior Level
$269K/yr - $449K/yrGSK is a global biopharma company focused on advancing health through innovative medicines and vaccines. The Global Study Manager will oversee the clinical operations of assigned studies, ensuring timely delivery, quality standards, and adherence to regulatory guidelines while collaborating closely with the Global Study Lead.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
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
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 utilization of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working
Qualification
Required
Bachelor's degree: life sciences or related discipline
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, analyze and solve problems systematically and creatively, and to take a risk-based approach
Benefits
Private healthcare
Additional paid days off
Life insurance
Private pension plan
Fully paid parental leave & care of family member leave
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Founded in 1929
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Luke Miels
Chief Executive Officer
Julie Brown
CFO
Recent News
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