Senior Clinical Study Administrator

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

This is what you will do:

The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements.

The CSA collaborates closely with the Project Manager Country Operations (PMCO) and other local study team members in COM such as Study Start Up (SSU) manager, Clinical Research Associates (CRA), Site Management Leads (SML) and Head of Country Operations (HCO) in delivering support in the conduct of clinical trials in region or country.

You will be responsible for:

• Providing support to the local study team in COM in achieving quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation)
• End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS) and other general trial support in the country or region as delegated or per assigned trials.
• Providing support to the local study team including for start up activities in start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation and preparation and approval of sites for activation, etc
• Collaborating with PMCO, CRAs, SSU manager and study vendors on the preparation, supports the handling and distribution of clinical trial supplies and maintenance of tracking information
• Act as a central point of contact for the local study team in COM for designated project communications, correspondence, and associated documentation.
• Input on the development and maintenance of project management and other global tracking tools (e.g: CTMS, smartsheets, etc).
• Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CSAs)
• Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region.
• Providing support to local COM team with local F2F study and team meetings (venue, cost, agenda, etc), support team teleconferences, assist with staff onboarding as required by country/region
• Depending on the country/region, the CSA may provide varying levels of COM support to the department rather than to assigned studies as needed.

You will need to have:

• Bachelor's Degree in a related discipline, preferably life science.
• Proficiency with MS Office Suite (excel, word, PowerPoint)
• Understanding of the drug development process either via education or experience in the life sciences field.
• Preferably minimum experience of 3 year in Development
• Excellent collaboration and interpersonal skills, unafraid to ask questions.
• Strong organizational skills and ability to manage competing priorities.
• Strong attention to detail
• Effective written and verbal communication skills

We would prefer for you to have:

• Prior experience working in clinical research
• Medical knowledge and ability to learn relevant Alexion rare disease areas.
• Ability to work in an environment of remote collaborators and in a matrix reporting structure
• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/ processes of delivering quality clinical trials with reduced budget and in less time.
• Team oriented and flexible; ability to respond quicky to shifting demands and opportunities
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

The annual base pay (or hourly rate of compensation) for this position ranges from $82,798 to $124,196. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

18-Sep-2026

Closing Date

01-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.