Senior Clinical Study Administrator

AstraZeneca•Boston, MA

3d•$82,798 - $124,196

About The Position

The Clinical Study Administrator (CSA) assists with coordinating study activities from start-up through execution and closeout within Country Operations Management (COM). The role supports quality and consistent trial deliverables that meet time, cost, and quality objectives and comply 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 the Study Start Up (SSU) manager, Clinical Research Associates (CRAs), Site Management Leads (SMLs), and Head of Country Operations (HCO), to support clinical trial conduct in the region or country. The CSA supports local study teams across assigned trial lifecycles, including site identification, feasibility, start-up, recruitment, data deliverables, and complete study documentation filing. Responsibilities include end-to-end electronic Trial Master File (eTMF) setup and maintenance, regulatory document and training-document tracking, milestone management in the Clinical Trial Management System (CTMS), and other trial support as delegated. The role also assists with start-up activities, site communications and documentation, clinical trial supply coordination and tracking, project communications, tracking tools, global process-standardization initiatives, local-language translations, regulatory submissions, meetings, and staff onboarding. Depending on the country or region, support may be provided to the COM department rather than to assigned studies. The position requires at least three years of experience with a bachelor's degree, proficiency with Microsoft Office, an understanding of the drug development process, strong organization and attention to detail, effective communication, and collaborative interpersonal skills. Prior clinical research experience, a life-science bachelor's degree, development experience, medical knowledge, and adaptability in remote, matrixed, and changing work environments are preferred.

Requirements

At least 3 years 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 life science is preferred.
A minimum of 3 years 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.
Positive approach to managing change for oneself, the team, and the business, and ability to view change as an opportunity to improve performance and add business value.
Ability to identify and champion more efficient and effective methods or processes for delivering quality clinical trials with reduced budget and in less time.
Team-oriented and flexible, with ability to respond quickly to shifting demands and opportunities.
Ability to understand technology's impact on projects and to use and develop computer skills while making appropriate use of systems and software in an e-enabled environment.

Responsibilities

Support the local COM study team in meeting quality and timeliness goals 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), track regulatory and team-training documentation, manage milestones in the CTMS, and provide other delegated trial support.
Support study 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 to prepare, handle, and distribute clinical trial supplies and maintain supply-tracking information.
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 Smartsheets.
Collaborate with local and global CSAs on initiatives to standardize processes within and 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 study and team meetings, including venue, cost, and agenda arrangements; support team teleconferences and staff onboarding as required.
Provide varying levels of COM department support rather than assigned-study support, depending on country or regional needs.