Clinical Research Associate Job at Alexion Pharmaceuticals!
Alexion Pharmaceuticals is inviting applications for the Clinical Research Associate (CRA) position in Munich, Germany. This Clinical Research Job offers an exciting opportunity for experienced clinical research professionals to manage site-level study delivery, ensure compliance with ICH-GCP guidelines, and help advance innovative therapies. The CRA will play a key role in monitoring, site management, and ensuring clinical trial excellence.
Job Details:
- Job Title: Clinical Research Associate
- Job Reference: R-235701
- Location: Munich, Germany
- Experience Required: Minimum 1 year CRA monitoring experience
- Travel Requirement: Up to 70% during busy periods
- Work Environment: Office-based with site visits (remote and onsite monitoring)
- Reporting Structure: Collaborative matrix structure
About the Company:
Alexion Pharmaceuticals, now part of AstraZeneca, is a global biopharmaceutical company focused on developing transformative therapies for rare diseases. The company is committed to innovation, scientific excellence, and improving patient outcomes worldwide.
With a strong emphasis on compliance, quality, and global collaboration, Alexion operates in accordance with international guidelines such as ICH-GCP and maintains high standards in clinical development.
Educational Requirements:
- Bachelor’s degree in a related discipline, preferably in Life Sciences, or equivalent qualification
- Solid knowledge of clinical development processes with a strong emphasis on monitoring
- Excellent knowledge of ICH-GCP guidelines
- Basic knowledge of GMP/GDP
- Good understanding of the drug development process
Key Responsibilities:
- Identification, selection, initiation, monitoring, site data review, and closeout visits (remote and onsite) in the Clinical Research Job
- Conduct monitoring activities in accordance with Clinical Monitoring Plan (CMP) timelines
- Drive site performance and proactively resolve study-related issues
- Train and support Investigators and site staff on study-related matters, including Risk-Based Quality Management (RBQM)
- As a Clinical Research Associate, you should develop recruitment plans and manage enrollment milestones
- Ensure monitoring KPIs remain within agreed quality ranges
- Prepare and finalize monitoring visit reports in CTMS
- At Alexion Pharmaceuticals, you must ensure the timely collection and upload of essential documents into the eTMF
- Support regulatory submissions to EC/IRB and Regulatory Authorities when required
- Contribute to investigator nomination and feasibility activities in the Clinical Research Job
- Escalate quality issues, compliance breaches, or regulatory concerns appropriately
- Collaborate during audits and regulatory inspections
Skills Required:
- Excellent knowledge of international guidelines (ICH-GCP) and local regulations
- Strong clinical study management and data management understanding
- Excellent attention to detail
- Strong written and verbal communication skills
- Excellent collaboration and interpersonal skills
- Good negotiation skills
- Ability to prioritize and manage multiple tasks with conflicting deadlines
- Proactive and assertive communication approach
- Flexibility and willingness to travel
- Valid driving license
Preferred Qualifications:
- Experience in all study phases and rare medical conditions
- Ability to work in remote and matrix reporting environments
- Ability to implement efficient processes for quality clinical trials
- Strong adaptability and change management mindset
Benefits of the Clinical Research Job:
- Opportunity to work with a globally recognized rare disease biopharma leader
- Exposure to international clinical trials and regulatory environments
- Career growth within a matrix global structure
- Inclusive and diverse workplace culture
- Competitive compensation aligned with industry standards
- Opportunity to collaborate with global study teams and internal stakeholders
