Preparation of high-quality EU-CTR submissions for clinical trials during the start-up phase
Submissions to ethics committees and regulatory authorities during the start-up phase (where applicable)
Timely collection of required, high-quality documents from study sites and upload to the eTMF
Creation, adaptation, and translation of submission-relevant documents
Coordination of and support with handling RFIs
Maintenance and updating of the CTMS with study site data during the start-up phase
Proactive acceptance of task packages in the Submission Expert Group
Contribution to process improvements, knowledge transfer, and best-practice sharing

An attractive pipeline and innovative products
Individual development opportunities and lifelong learning
Trust, appreciation, and room for participation in a focused, passionate team
A diverse, inclusive, and bias-free working environment that actively promotes differences and welcomes applications from all qualified individuals
A sustainable company that will be CO2-negative across the entire value chain by 2030
An attractive benefits package (e.g., EGYM Wellpass, Corporate Benefits, and more)

Study Start-up Manager, Cell Therapy

Key skills