Specialist, Global Clinical Solutions (Services)

Location: Warsaw Poland
Work model: Hybrid (3 days per week in office)

About the role

Global Clinical Solutions (GCS) delivers enterprise services and technology that enable Clinical Development across AstraZeneca. Within GCS GCS Services provide central enterprise-wide support for CTMS eTMF and License to Operate processes including Submissions/Financial Disclosure support Safety Letter distributions and outsourced studies.
As a Specialist GCS you will deliver centralized services set up and maintain systems and data and ensure compliance and quality to enable on-time cost-effective clinical program delivery across internal and external stakeholders.

What youll do

• Central services delivery: Provide enterprise-wide support for CTMS eTMF Submissions/Financial Disclosure Safety Letter distributions and outsourced studies.

• CTMS/eTMF setup and maintenance: Configure maintain and perform data quality checks in partnership with Study Teams and external partners ensuring standards completeness and consistency.

• License to Operate processes: Support operational compliance maintaining procedural and system documentation aligned with GxP and ICH GCP.

• Submissions/Financial Disclosure: Coordinate required financial disclosures and documentation for regulatory submissions with Development Operations and R&D Quality.

• Safety Letter distributions: Manage preparation tracking and timely distribution of safety letters to sites and stakeholders; align with Pharmacovigilance processes.

• Outsourced studies: Coordinate data and document flows with CROs monitor quality and timelines and facilitate onboarding/integration with AZ systems.

• Lifecycle management: Support business continuity and updates to standards training materials and procedural documentation for processes and tools.

• User community support: Deliver trainings facilitate knowledge sharing and promote best practices across GCS and AZ.

• Continuous improvement: Analyze usage of processes/tools identify efficiency opportunities and contribute to User Requirement Specifications and User Acceptance Testing.

• Workload management: Prioritize tasks to meet individual and team targets; participate in change initiatives.

Essential skills/experience

• Education: Bachelors degree or equivalent relevant qualification.

• Organizational and analytical skills: Proven ability to multitask manage time and deliver task-oriented outcomes.

• Systems proficiency: Strong computer literacy; ability to establish and maintain efficient ways of working.

• Communication: Excellent English written and spoken; strong stakeholder communication skills.

• Clinical knowledge: Good understanding of clinical study processes; awareness of ICH GCP and applicable regulations.

• Values: Demonstrated AZ Values & Behaviors; proactive risk/issue identification with solution-oriented mindset.

Desirable skills/experience

• Degree in biological sciences or health-related field.

• Experience in the pharmaceutical industry or clinical development/clinical study delivery.

• Programming/automation aptitude (e.g. basic SQL Python reporting).

• GxP training; experience training others on study support processes/procedures.

• Hands-on experience with CTMS eTMF Submissions/FD workflows Safety Letter distributions; collaboration with CROs.

What we offer

• Impact: Key role ensuring high-quality data and operational compliance across global clinical programs.

• Development: Exposure to a broad portfolio of systems/processes and participation in continuous improvement projects.

• Collaboration: Work with global cross-functional teams and external partners.