GSK
pharmaceutical
StudyManager
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“Study Manager at GSK. Skills: clinical trials, drug development, ICH-GCP, project management. Lead and coordinate the delivery of clinical and evidence generation studies. Monitor study conduct”
What You'll Achieve.
keep studies on time; keep studies on budget; keep studies compliant with standards
Industry & Context.
practical problem solving; Logical/analytical thinking; Inclination to spot patterns and outliers
What They're Looking For.
Must Have
3+ years of relevant work experience in a pharmaceutical/scientific environment, Knowledge of clinical trials, Knowledge of drug development process, Knowledge of ICH-GCP, Knowledge of clinical study delivery process, Knowledge of regulations, Knowledge of operational best practices, Knowledge of industry standards, Experience in using Trial Master File industry accepted standard, Project management skills, Analytical skills, Financial skills, Leadership skills, Excellent verbal and written communication in English, Knowledge of applicable clinical trial regulatory requirements, Skills in applying applicable clinical trial regulatory requirements, Ability to manage multiple competing priorities, Good planning skills, Good time management skills, Good prioritization skills, Logical/analytical thinking, Inclination to spot patterns and outliers, Quality mindset, Critical sense, Attention to details, Effective training skills, Mentoring skills, Knowledge of project finance principles, Knowledge of accounting principles, Excellent comprehension of Microsoft Office tools, Good stakeholder management skills, Good communication skills (oral and written), Interpersonal skills, Results driven, Efficient, Ability to adjust to work in cross-functional squads in the agile model
Nice to Have
preferably with analytical/financial skills
What You'll Do.
Lead and coordinate the delivery of clinical and evidence generation studies
Monitor study conduct
Identify risks/issues
Escalate risks/issues
Draft key clinical documents
Review key clinical documents
Coordinate meetings with internal teams
Coordinate meetings with external partners
Coordinate collaboration with internal teams
Coordinate collaboration with external partners
Support GSM in CRO oversight
Support CRO delivery of delegated activities
Serve as primary vendor contact
Provide country-level oversight
Oversee data completeness
Oversee regulatory compliance
Manage study communications
Oversee clinical supply
Oversee investigational product
Identify risks for clinical supply
Propose mitigations for clinical supply
Ensure eTMF inspection
Maintain completeness of study documentation
Maintain quality of study documentation
Oversee budget tracking
Oversee change orders
Ensure alignment with agreements
Escalate budget issues
Actively contribute to Study Leadership
Actively contribute to Central Study
Foster change adoption
How You'll Work.
Team & Collaboration
Work with study teams; Work with vendors; Work with country colleagues; Coordinate meetings and collaboration with internal teams; Coordinate meetings and collaboration with external partners (CROs, vendors); Actively contributes to Study Leadership and Central Study foster team dynamics and change adoption; Ability to adjust to work in cross-functional squads in the agile model
Communication Scope
Excellent verbal and written communication in English; Good stakeholder management and communication skills (oral and written)
Process & Methodology
Project management skills, Good planning skills, Good time management skills, Good prioritization skills
Full Job Description
As Study Manager You will lead and coordinate the delivery of clinical and evidence generation studies from planning through close-out. You will work with study teams, vendors, and country colleagues to keep studies on time, on budget, and compliant with standards. We value clear communication, practical problem solving, and a focus on quality. This role offers growth through exposure to global study delivery, the chance to shape ways of working, and meaningful impact aligned with our mission of uniting science, technology and talent to get ahead of disease together. **This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:** * Monitor study conduct and progress; identify, resolve and escalate risks/issues. * Draft and review key clinical documents (Protocol, ICF) and study plans. * Coordinate meetings and collaboration with internal teams and external partners (CROs, vendors). * Support GSM in CRO oversight and delivery of delegated activities. * Serve as primary vendor contact for study-specific deliverables. * Provide country-level oversight: recruitment, data completeness, deviations, regulatory compliance. * Manage study communications: meetings, newsletters, action logs and team rosters. * Oversee clinical supply and investigational product delivery; identify risks and propose mitigations. * Ensure eTMF inspection readiness; maintain completeness and quality of study documentation. * Oversee budget tracking, change orders and expenses; ensure alignment with agreements and escalate issues. * Actively contributes to Study Leadership and Central Study Teams; foster team dynamics and change adoption. **Why You?** Working arrangement This role is hybrid. You will be expected to work regularly from our office and collaborate with international colleagues. **Basic Qualification** We are seeking professionals with the following required skills and qualifications to help us achieve
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