Beschreibung

The Senior Clinical Trial Assistant provides essential oper
Senior Clinical Trial Assistant
The Senior Clinical Trial Assistant provides essential operational and administrative support across all phases of clinical studies. This role ensures high-quality documentation, compliance with regulatory standards, and smooth collaboration across internal and external stakeholders.
Senior Clinical Trial Assistant
Our client is a leading organization in clinical research and innovation, operating at the forefront of science and health.
They offer a dynamic and international working environment focused on excellence and continuous improvement.
Description
Support Clinical Project Managers in tracking study milestones and deliverables
Maintain and oversee Trial Master File (TMF/eTMF) completeness, quality, and compliance with industry standards
Prepare, review, finalize, and distribute clinical study documentation
Participate in study meetings, take minutes, and ensure timely follow-up of action items
Coordinate investigator and vendor payments in collaboration with relevant stakeholders
Assist in contract and budget tracking under supervision
Develop and maintain trackers, dashboards, and reports for effective study monitoring
Ensure accurate tracking of training records for study teams and site staff
Collaborate effectively with CROs, vendors, and investigator sites, ensuring alignment with sponsor expectations and smooth study execution
Demonstrate strong ownership by proactively managing responsibilities, handling challenges and conflicts constructively, and contributing to continuous process improvements
Profile
Bachelor's degree in life sciences, healthcare, or a related field
Minimum 4 years' experience in clinical trial support roles (CTA or similar) within pharmaceutical, biotech, or CRO environments
At least 3 years of hands-on experience managing TMF/eTMF systems; strong familiarity with electronic document management (paper-only TMF experience is insufficient)
Solid understanding of ICH-GCP guidelines, clinical trial lifecycle, and sponsor responsibilities
Experience working on both sponsor and/or CRO sides, with the ability to effectively collaborate across stakeholders
Strong data management skills, including collection, review, and analysis of clinical data in compliance with regulatory and industry standards
Excellent organizational skills with the ability to manage multiple priorities and ensure high-quality documentation
Strong communication skills, with transparency, ability to acknowledge mistakes, and constructive behavior during challenging situations or conflicts
Open and receptive to feedback, demonstrating the ability to incorporate input and continuously improve performance
Proactive, accountable, and solution-oriented mindset, with a high sense of responsibility and professionalism
Job Offer
Opportunity to work in a fast-paced, international clinical research environment
Exposure to innovative projects and cross-functional collaboration
12-month full-time contract with engaging and expert people jidc01cae6ait jit0626ait jpiy26ait