Local Study Associate Director (Field-US)

Introduction to role:

Are you ready to lead country-level delivery of pivotal cancer trials and turn complexity into high-quality data that changes lives? This is your opportunity to direct Local Study Teams across one or more studies, accelerating start-up, safeguarding quality, and ensuring every site is set up to succeed—so patients can access innovative treatments sooner.

You will join a fast-moving, purposeful environment focused on earlier detection and treatment, with strong emphasis on early-stage clinical trials. Working from start-up through close-out, you will bring together investigators, CRAs, CSAs and global partners to remove obstacles, optimize execution and deliver to plan. Can you see yourself orchestrating sites, timelines, and budgets to hit first-patient-in faster while maintaining uncompromising quality?

In this role, you will translate strategy into results at the country level—owning delivery, leading risk, and elevating performance. Your leadership will directly contribute to our ambition to make death from cancer a thing of the past by ensuring robust, timely data that fuels critical decisions.

Accountabilities:

• Has 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 submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.

• 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.

• 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 essential 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, leads, and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

• Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices 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 plans on country study level proactively leads sites, stakeholders, 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 wi