Integral Study Associate Introduction to role: This role is based in Barcelona, with an on‑site commitment of three days a week. Fluency in English is required. Are you ready to keep pivotal early oncology studies inspection‑ready and moving at pace, so promising science reaches patients sooner?
Do you thrive on orchestrating complex, multi‑country clinical work where your coordination, precision and initiative directly influence trial momentum and decision‑making? Accountabilities - Trial Master File stewardship: Set up, maintain and close out a complete, compliant TMF; coordinate regular quality checks and proactively address gaps to ensure continual inspection readiness.
- Document production and publishing readiness: Prepare study documents with strict template and version control; ensure packages are complete and ready for publishing in regulatory document management systems.
- Systems and tracking excellence: Set up, populate and accurately maintain study information in tracking systems and communication tools; guide team members in effective system use to improve transparency and speed.
- Materials, equipment and vendor coordination: Manage logistics and tracking of study materials and equipment; liaise with external service providers and third‑party vendors to keep deliverables on schedule and in scope.
- Financial support and reconciliation: Assist with invoice tracking and reconciliation to maintain financial accuracy and support timely payments.
- Metrics, audits and inspections: Compile study metrics and reports; coordinate documentation and responses to support audits and regulatory inspections with confidence.
- Meetings and stakeholder engagement: Lead practical arrangements and contribute to content for internal and external meetings, including study team, monitor and investigator meetings, as well as advisory boards.
- Approvals and communications: Track document approvals and completion status; prepare and distribute study correspondence and updates, newsletters and web content to keep stakeholders aligned.
- Continuous improvement and scale: From day one, deliver accurate, timely execution; over time, identify process opportunities across studies and help embed best practices that raise the bar for speed and quality globally.
Essential
Skills & Experience - University degree/Bachelor’s degree, or equivalent experience.
- Minimum of 1–2 years’ experience providing administrative/operational support to clinical studies.
- Knowledge of ICH‑GCP principles.
- Team oriented with a proactive approach.
- Ability to coordinate and prioritize multiple tasks and deliverables.
- High degree of flexibility.
- Demonstrated verbal and written communication skills.
Desirable
Skills & Experience - Good understanding of drug development.
- Experience supporting multi‑country clinical studies.
- Familiarity with Trial Master File management and quality control.
- Hands‑on experience with regulatory document management and clinical tracking systems.
- Vendor coordination and meeting operations experience. Equality and Diversity AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
📌 Global Study Associate (Barcelona)
🏢 Astrazeneca
📍 Barcelona
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