Regional Director of Clinical Affairs and CRO Europe based in Germany

Chronos Consulting; Deutschland; Vor Ort; EUR 100.000 - 130.000; Vollzeit

Zusammenfassung

A leading global medical device company seeks a Regional Director of Clinical Affairs in Germany. The role requires extensive clinical management experience and involves executing clinical trials while ensuring regulatory compliance. This position is critical for driving clinical strategies across the EU and collaborating with stakeholders to ensure success in clinical projects.

Qualifikationen

• 5+ years in clinical management within Medical Device or CRO.
• Proven success in Phase I-III clinical trials.
• Fluent in English; additional languages advantageous.

Aufgaben

• Translate business objectives into clinical trial requirements.
• Manage internal clinical teams and external vendors.
• Develop and manage budgets for clinical projects.

Kenntnisse

Leadership

Clinical Management

Regulatory Compliance

Program Management

Financial Skills

Data Management

Fluency in English

Ausbildung

BS, BA, BSN, RN or higher in Life Sciences

Tools

Electronic Data Capture Systems

Clinical Trial Management Systems

Jobbeschreibung

Regional Director of Clinical Affairs and CRO Europe based in Germany, Deutschland

Client:

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

474309774326

Job Views:

2

Posted:

23.06.2025

Expiry Date:

07.08.2025

Job Description:

Our client is a leading, global medical device company pioneering noninvasive surgical treatments.

The Regional Director of Clinical Affairs will work closely with senior management to translate business objectives into clinical trial requirements. This role is responsible for executing the EU clinical portfolio and managing the clinical staff.

Skills and Experience:

• BS, BA, BSN, RN, or higher in Life Sciences or related fields
• At least 5 years in clinical management within the Medical Device (Class 2B/3) or CRO industry; bio-pharmaceutical experience advantageous
• Additional 5+ years in clinical trial management
• Proven success in Phase I-III clinical trials
• Expertise in GCP, ICH, ISO guidelines; FDA/Health Canada experience beneficial
• Experience managing clinical staff, Core Labs, data management, biostatistics, safety reporting
• Knowledge of electronic data capture and clinical trial management systems
• Strong program management and financial skills
• Fluent in English; additional European languages advantageous
• Willing to travel up to 40% domestically and internationally

Responsibilities:

• Translate business objectives into clinical trial requirements, ensuring regulatory compliance
• Manage and develop internal clinical teams and external vendors
• Design clinical trials, develop protocols, and liaise with EU authorities
• Oversee investigator and site selection, contracting, and approvals
• Manage patient recruitment, enrollment, and study timelines
• Interpret and document clinical results for regulatory submissions
• Build collaborations with stakeholders and key opinion leaders
• Create SOPs ensuring GCP compliance
• Develop training materials for staff and sites
• Oversee investigator-sponsored studies
• Develop and manage budgets for clinical projects