About this role
Job title: Regulatory Submissions (Study Start-up) Manager
About the Role The role is a full-time, onsite Regulatory Submissions Manager based in Munich, responsible for efficiently managing global start-up activities within the clinical operations team and ensuring adherence to Sponsor specifications throughout the trial start-up process.
What You'll Do
- Efficiently manage and execute all aspects of global start-up according to Sponsor specifications
- Perform quality checks on submission documents and site essential documents
- Prepare and approve informed consent forms
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges
- Present during bid defenses, general capabilities meetings, and audits
What We're Looking For
- More than 5 years of experience in clinical research, preferably with a CRO; experience may include CRA or project management
- Knowledge and experience with Clinical Trial Applications within Europe
- Strong oral and written communication skills
- Fluency in English and German
Nice to Have
- Travel: Minimal
Compensation & 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
- Awards