Senior Clinical Trials Coordinator & eTMF Lead

Alexion Pharmaceuticals, Inc.; Boston (MA); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Health, dental, vision coverage

Paid time off

Retirement programs

Job summary

Alexion Pharmaceuticals, Inc. is seeking a Clinical Study Administrator to coordinate trial activities from start-up through close-out within Country Operations Management.

The CSA will work closely with PMCO, SSU, CRAs, and HCO to ensure timely and quality deliverables in accordance with GCP and Alexion SOPs. Responsibilities include end-to-end eTMF setup, regulatory document tracking, CDA delivery, and activation support.

Qualifications

• Bachelor's degree in life science or related field.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint).
• Understanding of drug development process through education or experience.
• Minimum 3 years in development or related field.

Responsibilities

• Coordinate study activities from start-up to close-out within Country Operations Management.
• Support local study team to ensure timely, quality trial deliverables.
• Lead eTMF setup and regulatory document tracking.
• Assist with site activation, CDA delivery, and contract-related activities.
• Collaborate with PMCO, CRAs, SSU manager and vendors on trial material handling.

Skills

MS Office proficiency

Communication skills

Organizational skills

Team collaboration

Attention to detail

Education

Bachelor's Degree in Life Science

Tools

CTMS

eTMF

Smartsheet

Job description

Alexion Pharmaceuticals, Inc. is seeking a Clinical Study Administrator to coordinate trial activities from start-up through close-out within Country Operations Management.

The CSA will work closely with PMCO, SSU, CRAs, and HCO to ensure timely and quality deliverables in accordance with GCP and Alexion SOPs. Responsibilities include end-to-end eTMF setup, regulatory document tracking, CDA delivery, and activation support.