Regulatory Submissions (Study Start-up) Manager

Medpace; München; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Flexible work environment

Competitive compensation and benefits

Competitive PTO packages

Structured career paths

Employee appreciation events

Health and wellness initiatives

Zusammenfassung

Medpace in Munich is seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. This role focuses on global start-up activities, regulatory submissions, and ensuring compliance within Europe, including CTR processes.

The position requires strong communication skills in English and German and office-based collaboration in Munich. The ideal candidate has 5+ years in clinical research, CRO exposure, and experience with Europe-bound Clinical Trial

Qualifikationen

• More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience.
• Knowledge and experience with Clinical Trial Applications within Europe.
• Strong oral and written communication skills.
• Fluency in English and German.

Aufgaben

• Efficiently manage and successfully 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.

Kenntnisse

Clinical research

CRO experience

Clinical Trial Applications

Communication skills

English & German fluency

Jobbeschreibung

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team in Munich. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Efficiently manage and successfully 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.

Qualifications

• More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience.
• Knowledge and experience with Clinical Trial Applications within Europe.
• Strong oral and written communication skills.
• Fluency in English and German.

Travel: Minimal

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