Clinical Study Administrator

Alexion•Boston, MA

About The Position

The Clinical Study Administrator (CSA) assists with coordinating clinical study activities from start-up through execution and closeout within Country Operations Management (COM). The role supports quality, consistency, and timely delivery of trial objectives in accordance with Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs), and applicable regulatory requirements. The CSA works closely with the Project Manager Country Operations (PMCO) and local study team members, including Study Start Up (SSU) managers, Clinical Research Associates (CRAs), Site Management Leads (SMLs), and the Head of Country Operations (HCO), to support clinical trial conduct in a country or region. Depending on the country or region, the CSA may provide support to the COM department generally rather than to specifically assigned studies. The listed annual base pay range is $82,798 to $124,196. The position is eligible for short-term incentive bonuses and, for salaried roles, equity-based awards. Benefits include qualified retirement programs, paid time off (including vacation, holidays, and leaves), and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

At least 1 year of experience with a bachelor's degree.
Proficiency with Microsoft Office Suite, including Excel, Word, and PowerPoint.
Understanding of the drug development process through education or experience in the life sciences field.
Excellent collaboration and interpersonal skills, including willingness to ask questions.
Strong organizational skills and ability to manage competing priorities.
Strong attention to detail.
Effective written and verbal communication skills.

Nice To Haves

Prior experience working in clinical research.
A bachelor's degree in a life science field is preferred.
One year of experience in Development is preferred.
Medical knowledge and ability to learn relevant Alexion rare disease areas.
Ability to work with remote collaborators and in a matrix reporting structure.
Ability to manage change positively and view it as an opportunity to improve performance and add business value.
Ability to identify and champion more efficient and effective processes for delivering quality clinical trials with reduced budget and in less time.
Team-oriented and flexible, with the ability to respond quickly to shifting demands and opportunities.
Ability to understand the impact of technology on projects and develop and use computer skills appropriately in an e-enabled environment.

Responsibilities

Support the local COM study team in delivering quality and timely study deliverables across trial lifecycles, including site identification, feasibility, start-up, recruitment, data deliverables, and complete study documentation filing.
Set up and maintain the electronic Trial Master File (eTMF), track regulatory documents and team training documentation, manage milestones in the Clinical Trial Management System (CTMS), and provide other trial support as delegated or assigned.
Support start-up activities, including delivery and negotiation of confidentiality disclosure agreements (CDAs), distributing and collecting documents, communicating with sites during contract negotiations, preparing site files, and preparing and approving sites for activation.
Collaborate with the PMCO, CRAs, SSU manager, and study vendors on clinical trial supply preparation, handling, distribution, and tracking.
Serve as a central contact for designated project communications, correspondence, and associated documentation for the local COM study team.
Contribute to the development and maintenance of project management and global tracking tools, including CTMS and Smartsheet.
Collaborate with local and global CSAs on initiatives to standardize processes across countries.
Assist with local-language translations and IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required.
Support local COM face-to-face study and team meetings, including venue, cost, and agenda arrangements; support team teleconferences; and assist with staff onboarding as required.
As needed, provide COM department support rather than support limited to assigned studies.