Regulatory Submissions (Study Start-up) Manager
Medpace
forschende pharmazeutische Industrie
München, Bayern - Deutschland
Senior Fachkraft / Projektleiter
Experteer Overview
In this role you will lead global start-up activities and ensure compliant, timely submissions within our clinical operations team in Munich. You will liaise with cross-functional teams to manage submission documents, informed consent, and regulatory reviews, shaping start-up strategies and resolving issues. Your work supports sponsor-driven trials and audits, driving efficient regulatory processes. This is a growth-focused opportunity in a mission-driven CRO that accelerates medical therapeutics.
Leistungen / Benefits
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Verantwortungsbereiche
- Manage and execute global start-up per Sponsor specifications
- Perform quality checks on submission documents and site essential documents
- Prepare and approve informed consent forms
- Review regulations to proactively address start-up issues
- Present during bid defenses, capabilities meetings, and audits
Zentrale Anforderungen
- >5 years in clinical research, preferably with a CRO
- Experience may include CRA or project management
- Knowledge of Clinical Trial Applications in Europe
- Strong oral and written communication skills
- Fluency in English and German
Stellenbeschreibung
In this role you will lead global start-up activities and ensure compliant, timely submissions within our clinical operations team in Munich…
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