Global Study Lead – Clinical Operations (EMEA)

ThermoFisher Scientific; Polska; Hybrid; PLN 300,000 - 420,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Global Study Manager/Lead to oversee clinical study operations from initiation to archiving for a leading bio-pharma client. You will generate robust delivery plans focused on upper quartile performance and coordinate with the Global Study Lead for end-to-end delivery of the study.

Role requires 5+ years of global study management, extensive oncology experience, and strong budget/vendor management skills.

Qualifications

• Bachelor’s degree in life sciences or related discipline; understanding of complex clinical development and regulatory processes.
• At least 5+ years of global study management experience.
• In-depth clinical research experience: study management, monitoring, data management.
• Oncology experience is highly desirable.
• End-to-end global study management experience across NA/EMEA/APAC/LATAM.
• Experience with protocol input, ICF, and risk management.
• Proven cross-functional leadership and budget/vendor management.
• Experience with regulatory inspections (FDA/EMA/MHRA/PMDA) is a plus.

Responsibilities

• Deliver operational study management to time, quality, and budget within company standards.
• Lead study teams and coordinate meetings and training.
• Develop and maintain Study Initiation, Activity, and Delivery Plans.
• Oversee TMF quality strategy, DCT setup, and vendor oversight.
• Manage recruitment tracking, eTMF filings, and safety plans.
• Identify and mitigate study risks; ensure clear stakeholder communication.
• Contribute input on protocol, informed consent form, and study plans.

Skills

Study management

Global delivery

Budget management

Vendor management

Cross-functional leadership

Clinical protocol ICF input

Risk management

Communication skills

Education

Bachelor’s degree in life sciences

Job description

Thermo Fisher Scientific is seeking a Global Study Manager/Lead to oversee clinical study operations from initiation to archiving for a leading bio-pharma client. You will generate robust delivery plans focused on upper quartile performance and coordinate with the Global Study Lead for end-to-end delivery of the study.

Role requires 5+ years of global study management, extensive oncology experience, and strong budget/vendor management skills.