Be the Working Group (WG) Lead for Clinical Operations
Be accountable for operational delivery of clinical study/studies to time, quality, and budget
Support decision-making at pace and lead study team to achieve overall study deliverables
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs
Proactively identify, oversee, and mitigate study risks
Ensure appropriate stakeholder communication, including study status, expectations, risks and issues
Effectively lead empowered matrix teams
Implement innovative approaches to study delivery through external facing advances in technology
Be responsible for operational input into protocol and informed consent form development
Lead and conduct investigator meetings and ensure continual inspection readiness
Override the activities of the countries participating in the study

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
Strong understanding of clinical study, drug development, sample management and associated quality requirements
Good project management skills
Able to lead and work within teams and networks across functional and geographical boundaries
Able to manage competing priorities, performance targets and project initiatives
Operational expertise in risk management and contingency planning
Effective at problem solving and conflict resolution
Able to manage change and uncertainty
Demonstrates experience in multicultural settings
Demonstrates versatility and ability to adapt to working across multiple TAs
Ability to think independently, analyse and solve problems systematically and creatively

Global Study Manager

Key skills