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Study Manager, Global Study Management
Thermo Fisher ScientificStudy Manager overseeing operational delivery for clinical studies at Thermo Fisher. Collaborating with internal and external teams to ensure study success and compliance with quality standards.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Works cross-functionally within internal and external partners to deliver operational tasks
- Ensures delivery of delegated operational tasks on time, quality, budget, and scientific requirements
- Supports study teams to achieve overall study deliverables in consultation with Global Study Lead and Global Study Manager
- Responsible for effective implementation of STOM ways of working and facilitation of key STOM ceremonies
- Collaborates closely with Study Leadership Team and Working Group Leads
- Monitors study conduct and progress, identifying and resolving risks/issues
- Reviews and leads development of key clinical documents and manuals
- Facilitates and maintains interactions and meetings with internal and external partners
Requirements
What you’ll need- At least 3+ years of relevant work experience in a pharmaceutical/scientific environment
- Knowledge of clinical trials, drug development process
- Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards
- Well familiar with key systems used in clinical trial delivery
- Experience in using Trial Master File industry accepted standard
- Project management skills (preferably with analytical/financial skills)
- Excellent verbal and written communication in English
Benefits
Comp & perks- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trialsdrug development processICH-GCPclinical study delivery processoperational best practicesTrial Master Fileproject managementanalytical skillsfinancial skills
Soft Skills
communicationcollaborationproblem-solvingleadership