Senior Clinical Study Administrator (CSA), Country Operations Management

Are you ready to make a difference in the world of clinical trials

As a Senior Clinical Study Administrator (CSA) within Country Operations Management (COM) youll 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

Accountabilities:
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.

Essential Skills/Experience:
Bachelors 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 3 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.

Desirable Skills/Experience:
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.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why on average we work a minimum of 50% of our days each month from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZenecas Alexion division youll 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 whats possible in healthcare!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.