Clinical Affairs Program Manager Germany

Chronos Consulting; Deutschland; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading global medical device company is seeking a Clinical Affairs Program Manager for Europe. This remote position requires management of clinical trials and collaboration with various stakeholders to ensure compliance with standards and successful project execution. Candidates should have a strong background in clinical management and extensive experience in trial phases.

Qualifikationen

• At least 3 years in clinical management within biopharmaceutical or device industry.
• 4+ years in clinical trial management.
• Successful track record in Phase I – III clinical trials.

Aufgaben

• Collaborate with stakeholders to execute clinical trials.
• Design clinical trials and develop protocols.
• Manage investigator and vendor selection and contracting.

Kenntnisse

Communication

Organizational Skills

Program Management

Financial Skills

Data Management

Biostatistics

Safety Reporting

Knowledge of GCP

Knowledge of ICH Guidelines

Knowledge of ISO Guidelines

Ausbildung

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

Tools

Electronic Data Capture Systems

Clinical Trial Management Systems

Jobbeschreibung

Job Description

Our client is a global medical device company, pioneering MR-guided focused ultrasound technology. They are seeking a Clinical Affairs Program Manager Europe. The role is remote (up to 40% travel) and based in Europe.

As part of the global clinical affairs team, you will develop strategies for executing clinical trials that demonstrate product safety and efficacy. Responsibilities also include managing clinical trial approvals with local IRBs and/or Competent Authorities.

Required Skills and Experience:

1. BS, BA, BSN, RN, or higher degree in Life Sciences or related fields
2. At least 3 years in clinical management within biopharmaceutical or device industry, CRO experience preferred
3. Additional 4+ years in clinical trial management
4. Successful track record in Phase I – III clinical trials
5. Knowledge of GCP, ICH, ISO guidelines; FDA/Health Canada experience is a plus
6. Experience managing Core Labs, data management, biostatistics, safety reporting
7. Familiarity with electronic data capture and clinical trial management systems
8. Strong communication, organizational, program management, and financial skills
9. Excellent English skills; additional languages are a plus
10. Ability to work independently and collaboratively
11. Willingness to travel up to 40% domestically and internationally

Responsibilities:

• Collaborate with stakeholders to execute clinical trials and investigator-sponsored studies
• Design clinical trials, develop protocols, and liaise with EU authorities
• Manage investigator and vendor selection and contracting
• Obtain IRB/EC approvals and oversee study progress
• Develop and manage budgets for clinical projects
• Interpret and document clinical results for regulatory submissions and publications
• Build collaborations with investigators and key opinion leaders
• Develop SOPs and ensure compliance with GCP, FDA, ISO standards
• Identify training needs and develop training materials