Senior Clinical Study Operations Lead

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

Benefits offered by this job

Health, dental, and vision coverage

Retirement plan

Paid time off

Job summary

The Clinical Study Administrator (CSA) at Alexion Pharmaceuticals, Inc. assists in coordinating study activities from start-up through execution and close-out within Country Operations Management to ensure quality and efficiency of trial deliverables under GCP and SOPs.

You will support local study teams across the lifecycle, manage eTMF and regulatory tracking, coordinate site activation, and collaborate with PMCO, CRAs, and vendors to maintain documentation and readiness for trials.

Qualifications

• Bachelor's degree in a related discipline, life sciences preferred.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint).
• Understanding of the drug development process in life sciences.
• Preferably minimum 3 years of development experience.
• Excellent collaboration and interpersonal skills.
• Strong organizational skills and ability to manage competing priorities.
• Strong attention to detail.
• Effective written and verbal communication skills.

Responsibilities

• Coordinate and support local study teams across lifecycle stages.
• Set up and maintain end-to-end eTMF and regulatory document tracking.
• Track training documentation, milestones, and CTMS activities.
• Assist with start-up activities, CDA delivery, and site activation prep.
• Collaborate with PMCO, CRAs, SSU manager, and vendors for trial materials.
• Serve as central point of contact for project communications and documentation.
• Contribute to global process standardization and cross-country collaboration.
• Assist with translations and regulatory submissions as required.

Skills

Collaboration

Interpersonal skills

Attention to detail

Written and verbal communication

Education

Bachelor's Degree in life sciences

Tools

MS Office Suite

Job description

The Clinical Study Administrator (CSA) at Alexion Pharmaceuticals, Inc. assists in coordinating study activities from start-up through execution and close-out within Country Operations Management to ensure quality and efficiency of trial deliverables under GCP and SOPs.

You will support local study teams across the lifecycle, manage eTMF and regulatory tracking, coordinate site activation, and collaborate with PMCO, CRAs, and vendors to maintain documentation and readiness for trials.