Global Study Manager

Description

• 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
• 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
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Qualifications

• 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.