Senior Global Clinical Study Operations Lead

Takeda; Warszawa; Vor Ort; PLN 180.000 - 240.000; Vollzeit

Zusammenfassung

Takeda in Warsaw, Poland is seeking a Senior Clinical Study Associate to join the Global Clinical Development Operations team. You will support the operational execution of global clinical studies and work closely with Clinical Study Managers and SETs to deliver study objectives in line with development plans, regulatory requirements, and Takeda standards.

The ideal candidate has 2–4 years in pharma or CRO, experience on Phase II/III trials, exposure to global trials, and fluency in English.

Qualifikationen

• Bachelor’s degree in Life Sciences, Health Sciences, Technology, or related discipline.
• Equivalent combinations of education, training, and experience will also be considered.

Aufgaben

• Proactively manage day-to-day clinical study activities, ensuring compliance with study protocols, ICH-GCP guidelines, and Takeda SOPs.
• Support medium to high complexity global clinical studies, with responsibility for one or more studies and/or programs.
• Collaborate closely with Clinical Study Managers and Study Execution Team members to deliver study objectives and timelines.
• Anticipate operational needs, identify risks, and contribute to effective issue resolution.
• Ensure study activities are executed in alignment with study-specific plans and the established operating model.
• Support study start-up activities and site activation processes.
• Track site activation progress and elevate issues when required.
• Review Site Initiation Visit (SIV) reports and Essential Document Packages (EDP) with Start-Up teams.
• Assist with the review and maintenance of study plans, documents, and operational deliverables.
• Maintain and update clinical trial systems and study documentation (CTMS, eTMF, COMPASS).
• Support inspection readiness activities and documentation quality.
• Contribute to sponsor oversight and vendor management activities.
• Review site monitoring visit reports and track vendor deliverables and budgets.
• Lead delegated close-out activities and support audit/inspection readiness.

Kenntnisse

Clinical study coordination

Global trials experience

Phase II/III experience

CTMS

eTMF

Vendor oversight

Cross-functional collaboration

English fluent

Ausbildung

Bachelor’s degree in Life Sciences or related

Tools

CTMS

eTMF

COMPASS

Jobbeschreibung

Takeda in Warsaw, Poland is seeking a Senior Clinical Study Associate to join the Global Clinical Development Operations team. You will support the operational execution of global clinical studies and work closely with Clinical Study Managers and SETs to deliver study objectives in line with development plans, regulatory requirements, and Takeda standards.

The ideal candidate has 2–4 years in pharma or CRO, experience on Phase II/III trials, exposure to global trials, and fluency in English.