Local Study Associate Director

To lead 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, international guidelines such as ICH-GCP as well

as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site

monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified,

site qualifications performed, set up, initiated, monitored, closed and documentation archived.

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 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, manages 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 complex study problems and issues.

• Organises 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 stakeholders.

• 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 necessary.

• Develops, maintains and reviews risk management plan on country study level: proactively manages 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 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 organised at country level.

• Ensures accurate payments related to the study are performed according to local regulations and agreements.

• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents.

• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

• Provides input to process development and improvement.

• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.

• Updates Line Managers about the performance of the CRAs/CSAs.

• Ensures that study activities at country level comply with local policies and code of ethics.

• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

• Collaborates with local Medical Affairs team.

• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Qualifications:

· Bachelor’s degree in relevant discipline

· 5+ years of relevant experience

· Significant experience in Study Management within a pharmaceutical or clinical background

· Thorough knowledge of Patient Safety processes and local regulations

The annual base pay for this position ranges from $137,937.60 - $206,906.40USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

01-Apr-2026

Closing Date

10-Apr-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.