30 jul
|
Astrazeneca
|
España
30 jul
Astrazeneca
España
Introduction to role
Are you ready to lead country‑level clinical study delivery that accelerates breakthrough medicines to patients? As Local Study Associate Director, you will turn complex operational challenges into precise execution that safeguards data quality, drives recruitment, and keeps studies inspection‑ready.
In this role, you will lead Local Study Teams across multiple sites, aligning seamlessly with the General Study Team to deliver on country commitments with pace and rigor. You will be accountable for end‑to‑end study execution in country—feasibility, site selection, submissions, monitoring, data delivery, and close‑out—while ensuring full adherence to ICH‑GCP, local regulations, and AstraZeneca standards.
Do you thrive in a matrix environment where your decisions shape timelines, budget stewardship, and stakeholder confidence?
You will leverage clinical operations expertise, risk‑based thinking, and technology to remove barriers, anticipate issues, and enable high‑quality, on‑time delivery. Your leadership will connect investigators, monitors,
and cross‑functional partners to the shared goal of generating robust evidence that can transform patient care.
Accountabilities
- Country Study Ownership: Hold overall responsibility for country‑level study commitments, timelines, and high‑quality data delivery aligned with the Global Study Team.
- Local Study Team Leadership: Lead CRAs, CSAs, and other contributors; set clear expectations, coach for performance, and cultivate a culture of accountability.
- Compliance and Quality Governance: Drive compliance with AstraZeneca procedures, ICH‑GCP, and local regulations; embed quality by design and inspection readiness from first site to last patient out.
- Feasibility and Site Strategy: Coordinate feasibility, site selection, qualification, and risk assessments to activate the right sites quickly and sustainably.
- Ethics/Regulatory Submissions: Ensure timely, complete submissions to Ethics Committees/IRBs and s
📌 Local Study Associate Director Biopharma (España)
🏢 Astrazeneca
📍 España