Local Study Associate Director / Local Study Lead (Oncology)

at  AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
It’s our patients that come first, every decision we make and action we take is centred around how we can better respond to their evolving needs, as well as those of healthcare professionals and partners. It’s why we are shaping patient care for the future, working along the whole experience to give hope to billions of lives across the world.

WHAT YOU’LL DO

As a Local Study Associate Director, you will be leading the Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents and international guidelines such as ICH-GCP as well as relevant local regulations.
In addition to leading LST(s), as the Local Study Associate Director (LSAD) you may perform site monitoring as needed to support the flexible capacity model.

KEY RESPONSIBILITIES

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Proactively identifies risks and facilitates resolution of complex study problems and issues.