Clinical trials information system (ctis) expertise
Initial clinical trial application preparation
The role is responsible for managing the entire lifecycle of clinical trial submissions from initial application through end-of-study reporting in compliance with EU CTR 536/2014
Job Summary
The role is responsible for managing the entire lifecycle of clinical trial submissions from initial application through end-of-study reporting in compliance with EU CTR 536/2014.
Candidates must possess hands-on experience with the Clinical Trials Information System (CTIS) to manage dossier creation, uploads, and lifecycle activities.
Biogen offers a competitive total rewards package including an annual bonus, comprehensive family benefits, and professional development funding.
Matching Summary
The role is responsible for managing the entire lifecycle of clinical trial submissions from initial application through end-of-study reporting in compliance with EU CTR 536/2014.
Salary
Base: 162,000 - 216,750 PLN gross; Bonus: Annual performance-based bonus; Benefits: Life insurance, pension, mental health resources, flexible work arrangements
Skills & Requirements
Must-have
EU Clinical Trial Regulation (EU CTR) compliance
Clinical Trials Information System (CTIS) expertise
Initial Clinical Trial Application preparation
Substantial Modifications and safety notifications
End-of-study reporting and public disclosure
Nice-to-have
Strong organizational and multitasking skills
Analytical problem-solving abilities
Experience in pharmaceutical or biotech environment
Effective cross-functional collaboration
Adaptability to evolving regulatory expectations
Key Requirements
Bachelor's degree in Life Sciences or related field
1-3+ years of experience in EU clinical trial submissions