Clinical Study Administrator

AstraZeneca•Boston, MA

4d•$82,798 - $124,196

About The Position

The Clinical Study Administrator (CSA) assists with coordinating study activities from start-up through execution and close-out within Country Operations Management (COM). The role supports quality and consistency of trial deliverables against time, cost, and quality objectives, in accordance with Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs), and evolving 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). Depending on the country or region, the CSA may support assigned studies or provide broader support to the COM department.

Requirements

At least 1 year of experience with a bachelor's degree.
Proficiency with the MS 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 life science 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 ways to deliver quality clinical trials with reduced budgets and timelines.
Team-oriented and flexible, with the ability to respond quickly to changing demands and opportunities.
Ability to understand the impact of technology on projects and to use and develop computer skills in an e-enabled environment.

Responsibilities

Support the local COM study team in achieving quality and timely deliverables across assigned trials, including site identification, feasibility, start-up, recruitment, data deliverables, and complete study documentation filing.
Set up and maintain the electronic Trial Master File (eTMF) end to end; 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 CDA delivery and negotiation, document distribution and collection, site communications during contract negotiations, Site File preparation, and site activation preparation and approval.
Collaborate with the PMCO, CRAs, SSU manager, and study vendors on the preparation, handling, and distribution of clinical trial supplies and maintenance of tracking information.
Serve as a central point of contact for designated project communications, correspondence, and related documentation for the local COM study team.
Contribute to the development and maintenance of project management and global tracking tools, such as CTMS and Smartsheet.
Collaborate on global initiatives to standardize processes across countries with local and global CSAs.
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.
Provide varying levels of departmental COM support, depending on country or regional needs.