Local Study Associate Director

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Note this is a 12-month contract.**

**Introduction to role**

Are you ready to lead and inspire Local Study Teams (LSTs) at the country level? As a Local Study Associate Director (LSAD), you will be at the forefront of delivering clinical studies, ensuring they meet agreed resources, budgets, and timelines. You will ensure compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading LSTs, you may also perform site monitoring as needed to support the flexible capacity model. Your role will be crucial in identifying sites, performing site qualifications, setting up, initiating, monitoring, closing, and archiving documentation.

**Accountabilities**
- 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 optimizes 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.
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.
- Ensures all country and site level trial crucial documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
- Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, handles and coordinates supervising activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews supervising visit reports (as required and following AZ SOPs) and pro-actively advises the monitor(s) on study-related matters.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Proactively identifies risks and facilitates resolution of sophisticated study problems and issues.
- Organizes regular Local Study Team meetings on an agenda-driven basis.
- Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global partners.
- Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
- Contributes to patient recruitment strategy including regular communication with participating Investigators as vital.
- Develops, maintains and reviews risk management plan on country study level: proactively manages sites, collaborators, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
- Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
- Plans and leads National Investigator meetings, in line with local codes, as required.
- Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Ensures relevant systems required to facilitate business-critical, license-to-operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.
- Ensures accurate payments related to the study are performed according to local regulations and agreements.
- Participates in training and c