Local Study Associate Director – SMM

About AstraZeneca: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. We are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

As a Local Study Associate Director, you will spearhead Local Study Teams (LSTs) to deliver key components of clinical trials, ensuring compliance with AstraZeneca's Procedural Documents, international guidelines like ICH-GCP, and local regulations. Your role will be pivotal in identifying and qualifying sites, overseeing site monitoring, and ensuring seamless documentation processes.

Key Responsibilities:

• Take full responsibility for study commitments within the country, ensuring timely delivery of high-quality data.
• Lead and optimize the performance of Local Study Teams, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
• Conduct clinical and operational feasibility assessments for potential studies with precision.
• Coordinate site selection by identifying potential sites/investigators and conducting Site Qualification Visits.
• Ensure timely submission of applications/documents to EC/IRB and Regulatory Authority throughout the study.
• Prepare and maintain accurate study budgets and agreements in AZ's financial system.
• Oversee monitoring activities from site activation to study closure, ensuring adherence to Monitoring Plans.
• Proactively identify risks and resolve complex study problems.
• Foster strong relationships with Local Study Team members, sites’ staff, and global collaborators.
• Report study progress to the Global Study Associate Director/Global Study Team.
• Develop patient recruitment strategies and lead risk at the country study level.
• Organize National Investigator meetings and assist in forecasting study timelines and resources.

Requirements:

• Bachelor degree in related field, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Shown ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Shown project management skills.
• Excellent team building and interpersonal skills.
• Excellent organisational skills.
• Excellent attention to details.
• Good negotiation skills.
• Ability to travel nationally and internationally as required.

Desirables:

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Very good understanding of the Study Drug Handling Process and the Data Management Process.
• Integrity and high ethical standards.
• Good analytical skills.
• Ability in handling crisis situations.

Why AstraZeneca?

At AstraZeneca's Oncology R&D business area, you will be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We are actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical.

Competitive Salary And Benefits Package On Offer. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, a performance recognition scheme and a competitive, generous remuneration package.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best.