Senior Clinical Research Associate - 70% Travel

Alexion Pharmaceuticals, Inc.; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. seeks a Senior Clinical Research Associate (Sr. CRA) to provide local delivery of studies at allocated sites and act as the primary site contact.

You will ensure study conduct aligns with ICH-GCP and local regulations, collaborating with PMCO, SSU, CSA, and other CRAs to meet country commitments. The Sr. CRA will oversee initiation, monitoring, and closeout visits (remote/onsite), drive site performance, support recruitment plans, and manage data in CTMS/eTMF.

Qualifications

• Minimum of 4 years of CRA monitoring experience.
• Bachelor’s degree in life science or related field.
• Excellent knowledge of ICH-GCP and local regulations.
• Ability to learn Alexion Therapeutic Areas.
• Excellent written and verbal communication skills.
• Willingness to travel up to 70%.

Responsibilities

• Perform site selection, initiation, monitoring and closeout visits (remote and onsite).
• Drive site performance and resolve study-related issues promptly.
• Train and advise Investigators and site staff on study matters, including RBQM.
• Develop recruitment plans and support enrollment milestones.
• Monitor KPIs and ensure data quality targets are met.
• Prepare monitoring visit reports in CTMS and provide timely feedback.
• Ensure timely collection/uploading of essential documents into the eTMF.
• Support regulatory start-up and submissions as needed.
• Collaborate with internal stakeholders and auditors.

Skills

CRA monitoring

ICH-GCP knowledge

Travel readiness

Communication skills

Driving license

Education

Bachelor’s degree in life science or related

Job description

Alexion Pharmaceuticals, Inc. seeks a Senior Clinical Research Associate (Sr. CRA) to provide local delivery of studies at allocated sites and act as the primary site contact.

You will ensure study conduct aligns with ICH-GCP and local regulations, collaborating with PMCO, SSU, CSA, and other CRAs to meet country commitments. The Sr. CRA will oversee initiation, monitoring, and closeout visits (remote/onsite), drive site performance, support recruitment plans, and manage data in CTMS/eTMF.