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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Madrid, Spain, Prague, Czechia, Warsaw, Masovian, Poland

Job Description:

Position Summary:

The Senior CTISA is responsible for assisting with the operational components of all clinical trial applications submitted under the EU Clinical Trial Regulation (EU CTR) within the Clinical Trial Information System (CTIS). This individual will collaborate with the Clinical Trial Submission Coordinator (CTSC), regulatory stakeholders, and Global Country Operations (GCO) teams to ensure that all clinical trial applications are submitted in CTIS, monitor the application's progress, and ensure the proper archiving of relevant documentation.

Principal Responsibilities:

Ensure complete and timely entry of application specific information into CTIS. Upload the application package to CTIS, submit it within the system, and archive relevant documentation in internal source systems. Perform document quality and completeness checks. Support submission coordination efforts and track timelines and deliverables to ensure trials are delivered according to agreed schedules and milestones. Perform relevant quality oversight and inspection readiness activities. Assist CTSC, Regulatory and clinical stakeholders with applicable CTIS support. Maintain expertise in CTIS operations to address inquiries from within the organization. Demonstrate leadership at the trial level for complex or challenging trial applications. Understand the responsibilities of the CTSC and collaborate effectively to ensure timely submissions. Contribute to the development of processes or optimization of operational models. Serve as a Subject Matter Expert (SME) in designated areas. Mentor newly onboarded CTISAs Exhibit strong communication skills and engage in cross-functional discussions, both internally and externally. Undertake additional activities as assigned by the Functional Manager.

Principal Relationships:

This position reports to the Manager of EU CTR and will collaborate closely with the Clinical Trial Submission Coordinator.

Education and Experience Requirements:

• Bachelor’s degree

• Minimum of 2 years of relevant EU CTR experience with associated skill sets.

• Deep understanding and demonstrated proficiency of the Clinical Trial Information System.

• Excellent organization skills, excellent written and verbal communication skills.

• Excellent independent time management skills.

• Proven ability to plan and track deliverables and timelines.

• Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.

• Demonstrate proficiency with Microsoft Office applications.

• Ability to mentor and train others.

• Language requirements: Fluency in English

 

 

Required Skills:

 

 

Preferred Skills: