Global Study Manager
GSK
full-time
Posted on:
Location Type: Hybrid
Location: London • United Kingdom
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Tech Stack
About the role
- 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
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
- 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
Benefits
- Salary competitive
- Annual bonus based on company performance
- Healthcare and wellbeing programmes
- Pension plan membership
- Shares and savings programme
- Hybrid working model
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchstudy managementmonitoringdata managementproject managementrisk managementcontingency planningprotocol developmentinformed consent form developmentstudy delivery
Soft Skills
stakeholder managementcommunication skillsinterpersonal skillsleadership skillsproblem solvingconflict resolutionadaptabilitymotivationempowermentteamwork