Clinical Study Administrator

AstraZeneca GmbH; Warszawa; Hybrid; PLN 55,000 - 85,000; Full time

Benefits offered by this job

Multisport card

Pension plan

Life insurance

After-work events

Private medical care

Lunch card

Bright and spacious environment

Sustainable office working environment

Job summary

AstraZeneca GmbH in Warsaw is seeking a Clinical Study Administrator to coordinate trial activities from start-up to close-out within Country Operations Management. The role requires collaboration with PMCO, CRA, SSU and HCO teams to ensure quality, timeliness and adherence to GCP and SOPs.

The CSA will manage eTMF setup, regulatory tracking, and global and local documentation, with a hybrid model of 3 days in the office per week.

Qualifications

• Bachelor's degree in a life sciences field.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint).
• Understanding of the drug development process.
• Preferably 1 year of development experience.
• Excellent collaboration and interpersonal skills.
• Strong organizational skills and ability to manage competing priorities.
• Strong attention to detail.
• Effective written and verbal communication skills.

Responsibilities

• Support local study team in COM ensuring quality and timely trial deliverables across lifecycle.
• End-to-end eTMF set-up and maintenance, regulatory document tracking and CTMS milestone management.
• Support start-up activities: CDA delivery, document distribution, site activation prep.
• Collaborate with PMCO, CRAs, SSU manager and vendors on trial supplies and tracking.
• Be the central contact point for project communications and documentation in COM.
• Assist with development and maintenance of global tracking tools (CTMS, Smartsheets).
• Collaborate on global initiatives to standardize processes across countries.

Skills

Bachelor's Degree in related field

MS Office proficiency

Drug development understanding

1 year development experience (pref.)

Collaborative skills

Organizational skills

Attention to detail

Written and verbal communication

Education

Bachelor's degree in life sciences or related

Tools

CTMS

eTMF knowledge

Job description

Clinical Study Administrator

Location: Warsaw

Hybrid Model: 3 days per week from office

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

The Clinical Study Administrator (CSA) assists in the coordination of study activities from the start up to execution and close out within Country Operations Management (COM) to ensure quality and consistency of trial deliverables to time, cost and quality objectives according to Good Clinical Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements.

The CSA collaborates closely with the Project Manager Country Operations (PMCO) and other local study team members in COM such as Study Start Up (SSU) manager, Clinical Research Associates (CRA), Site Management Leads (SML) and Head of Country Operations (HCO) in delivering support in the conduct of clinical trials in region or country.

You will be responsible for:

• Providing support to the local study team in COM in achieving quality and timeliness of study deliverables across the lifecycle of assigned trials (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation)
• End to end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, tracking of team training documentation, milestone management in the Clinical Trial Management System (CTMS) and other general trial support in the country or region as delegated or per assigned trials.
• Providing support to the local study team including for start up activities in start-up phase: CDA delivery and negotiation, distribution and collection of documents, communication with sites during contract negotiation phase, Site File preparation, and preparation and approval of sites for activation, etc
• Collaborating with PMCO, CRAs, SSU manager and study vendors on the preparation, supports the handling and distribution of clinical trial supplies and maintenance of tracking information
• Act as a central point of contact for the local study team in COM for designated project communications, correspondence, and associated documentation.
• Input on the development and maintenance of project management and other global tracking tools (e.g: CTMS, smartsheets, etc).
• Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global CSAs)
• Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region.
• Providing support to local COM team with local Face-to-Face study and team meetings (venue, cost, agenda, etc), support team teleconferences, assist with staff onboarding as required by country/region
• Depending on the country/region, the CSA may provide varying levels of COM support to the department rather than to assigned studies as needed.

You will need to have:

• 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 1 year 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

We would prefer for you to have:

• 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 quicky 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.

What we offer:

Welcome toWarsaw Site,one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca's priorities, it's important to us that you bring your full self to work every day.

To help you maintain your best self, here's a sneak peek into some of the things this site provides for you:

• The best team to support you,
• Multisport card,
• Pension plan,
• Life insurance,
• after-work events,
• private medical care
• lunch card,
• bright and spacious environment,
• sustainable office working environment.

Please note that we are working in a hybrid model of 3 days per week from the office in Warsaw

Date Posted

19-sie-2026

Closing Date

27-sie-2026

Alexion is proud to be an Equal Employment Opportunity and Affir 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 status,pregnancy, (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 [e-mail]. Alexion participates in E-Verify.