Global Study Manager: Clinical Trial Delivery & eTMF

ThermoFisher Scientific; Polska; Hybrid; PLN 260,000 - 340,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Study Manager to drive end-to-end operational study delivery, coordinate internal and external stakeholders, and ensure inspection readiness. The role focuses on maintaining eTMF completeness, risk management, and budget oversight within a global study team.

Ideal candidates bring 3+ years in pharma/scientific environments, strong leadership, and excellent English communication, with deep knowledge of ICH-GCP and trial management processes.

Qualifications

• University degree or equivalent, preferably in medical or biological science.
• At least 3+ years of relevant work experience in pharmaceutical/scientific environment.
• Excellent knowledge of ICH-GCP and clinical study delivery processes.
• Strong project management and leadership skills.

Responsibilities

• Partner with Study Delivery Lead on end-to-end operational study delivery from setup to archival.
• Maintain and ensure completeness of internal systems, databases, and project plans.
• Monitor study conduct, identify and escalate risks impacting quality, timeline, or budget.
• Develop and lead study plans (Monitoring, Vendor Management, Protocol Deviations, Risk) for internal/external use.
• Coordinate interactions with regulatory, QA, monitors, CROs and vendors to ensure delivery of studies.
• Oversee vendor management and CRO oversight, tracking deliverables and issues.

Skills

Project management

Stakeholder management

Analytical thinking

Problem solving

Leadership

Cross-functional teamwork

Education

University degree in medical or biological science

Tools

Microsoft Office

Clinical trial management systems

Job description

Thermo Fisher Scientific is seeking a Study Manager to drive end-to-end operational study delivery, coordinate internal and external stakeholders, and ensure inspection readiness. The role focuses on maintaining eTMF completeness, risk management, and budget oversight within a global study team.

Ideal candidates bring 3+ years in pharma/scientific environments, strong leadership, and excellent English communication, with deep knowledge of ICH-GCP and trial management processes.