Senior Clinical Study Administrator

AstraZeneca

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 helps ensure quality and consistent trial deliverables 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 a country or region. Depending on the country or region, the role may provide departmental COM support rather than support for assigned studies.

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.
Preferably at least 3 years of experience in Development.
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 methods and processes for delivering 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 technology's impact 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 outputs throughout assigned trials, including site identification, feasibility, start-up, recruitment, data deliverables, and filing complete study documentation.
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 country or regional 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 preparation and approval for activation.
Collaborate with the PMCO, CRAs, SSU manager, and study vendors on preparation and handling of clinical trial supplies, their distribution, and tracking information maintenance.
Serve as a central point of 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 other 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 by the country or region.