Study Manager, Global Study Management
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Job Description
Study 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.
Responsibilities:
- 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:
- 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:
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development
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