Global Study Manager

Job Summary

This role within GCSD plays a pivotal part in driving the clinical operations of assigned studies, from Commit to Study Initiation (CSI) all the way through to study archiving. As a Global Study Manager (GSM), you'll take ownership of crafting robust, accelerated delivery plans that aim for top-tier performance-ensuring timelines, quality standards, and ambitious targets are consistently achieved.

Collaborating closely with the Global Study Lead (GSL), you'll contribute to the seamless end-to-end delivery of the clinical study. As the GSM, you will lead the Operational Working Group (for in-house studies) and actively participate as a key member of the Central Study Team (CST). This is a dynamic and impactful role designed for individuals driven to make a meaningful difference in clinical operations.

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
• 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
• This role follows GSK's Performance with Choice flexible-working approach-balancing individual flexibility with team collaboration-and requires on-site attendance 2-3 days per week to support core team activities and business needs. Candidates are required to live in proximity to a GSK hub.

Education Requirements

• Bachelor's degree: life sciences or related discipline
• The role will require a good understanding of complex clinical development and regulatory processes.

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, analyze and solve problems systematically and creatively, and to take a risk-based approach.

We are looking for someone who thrives in a collaborative environment, is passionate about delivering results, and is eager to make a difference.

Skills

• Agile Thinking
• Business Acumen
• Clinical Development
• Clinical Document Management
• Clinical Trial Designs
• Clinical Trials Monitoring
• Communication
• Creativity
• Decision Making
• Fostering Collaboration
• Good Clinical Practice (GCP)
• Influencing Without Authority
• Pharmaceutical Industry
• Project Management
• Time Management