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Study Start-up Manager, Cell Therapy
AstraZenecaStudy Start-up Manager responsible for high-quality EU-CTR submissions for clinical trials at AstraZeneca. Coordinating with study centers and ensuring document compliance during the start-up phase.
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Degree in Life Sciences (e.g., Biology, Pharmacy) or equivalent qualification
- Experience with initial clinical trial submissions in CTIS and RFI handling
- Understanding of basic study and process requirements
- Independent, structured, and efficient working style
- Team player with confident, goal-oriented communication
- Strong assertiveness
- Excellent German and English language skills
- Proficient in MS Office
Benefits
Comp & perks- 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)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial submissionseTMFCTMSRFI handlingdocument creationdocument translationprocess improvementsknowledge transferbest-practice sharing
Soft Skills
independent workingstructured workingefficient workingteam playergoal-oriented communicationstrong assertiveness
Certifications
degree in Life Sciences