Global Study Manager

GSK•Mississauga, ON

3d•Hybrid

About The Position

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.

Requirements

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

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