Clinical Study Administrator (CSA), Country Operations Management

Alexion Pharmaceuticals, Inc.•Milan, TN

38d•Hybrid

About The Position

Are you ready to make a difference in the world of clinical trials? As a Clinical Study Administrator (CSA) within Country Operations Management (COM), you'll play a pivotal role in coordinating study activities from start-up to execution and close-out. Your mission is to ensure quality and consistency in trial deliverables, meeting time, cost, and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs), and evolving regulatory requirements. Collaborate closely with the Project Manager Country Operations (PMCO) and other local study team members, including Study Start-Up (SSU) managers, Clinical Research Associates (CRA), Site Management Leads (SML), and Head of Country Operations (HCO), to support the conduct of clinical trials in your region or country. Are you ready to take on this challenge? When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why, on average, we work a minimum of 50% of our days each month from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca's Alexion division, you'll find an environment where innovation thrives! Our entrepreneurial spirit combined with global resources allows us to make a significant impact on patients' lives. We are committed to fostering a culture that celebrates diversity, inclusiveness, and collaboration. Here, you can grow your career while contributing to groundbreaking advancements in healthcare. Our dedication to patients living with rare diseases drives us forward every day. Ready to embark on this exciting journey? Apply now and be part of a team that is redefining what's possible in healthcare!

Requirements

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 2 years 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.

Nice To Haves

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 quickly 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.

Responsibilities

Provide support to the local study team in COM to achieve quality and timeliness of study deliverables across the lifecycle of assigned trials.
Manage end-to-end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, team training documentation, milestone management in the Clinical Trial Management System (CTMS), and other general trial support.
Support start-up activities, including CDA delivery and negotiation, document distribution and collection, communication with sites during contract negotiation, Site File preparation, and site activation approval.
Collaborate with PMCO, CRAs, SSU managers, and study vendors on clinical trial supplies preparation, handling, distribution, and tracking information maintenance.
Act as a central point of contact for designated project communications, correspondence, and associated documentation.
Input on the development and maintenance of project management and other global tracking tools.
Collaborate in global initiatives to standardize processes within and across countries.
Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions.
Provide support for local COM team meetings, teleconferences, and staff onboarding as required.
Depending on the country/region, provide varying levels of COM support to the department rather than assigned studies as needed.