Local Study Associate Director (Biopharma)

Job Description

Short Role Description

The Local Study Associate Director (LSAD) is responsible for managing their assigned clinical studies and leading Local Study Teams (LSTs) to ensure delivery of country-level study commitments according to agreed budgets, timelines and resources assigned by Director Country Head (DCH) or Director Site Management & Monitoring (DSMM). All activities must comply with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. This role reports to DCH or DSMM, depending on country-specific organisational set-up and works in alignment with Global Study Team (GST), for delivery of assigned studies. Beyond leadership of LSTs, the LSAD may also engage in site monitoring activities as required, supporting the flexible capacity model. The LSAD ensures that study sites are appropriately identified, qualify for participation, are set-up, initiated, and monitored throughout the study, and that closure and archiving of site documentation are completed according to standards. This Job description applies to both senior and non-senior role levels with additional responsibilities and expectations applicable for the senior role, defined in document ‘Site Management and Monitoring (SM&M) Biopharmaceuticals Senior Role Definition’ (GUID-0028372).

Typical Accountabilities

Accountabilities for this role include

• Hold overall responsibility for fulfilling country-level study commitments and ensuring timely, highquality data delivery.
• Lead the Local Study Team(s)—comprising Clinical Research Associate’s (CRAs), Clinical Study Administrator’s (CSAs), and other contributors—for assigned studies, fostering collaboration and high performance.
• Drive optimal performance and compliance of Local Study Team(s) with AstraZeneca Procedural Documents, ICH-GCP requirements, and local regulations.
• Ensure the highest quality in the clinical and operational feasibility assessment of potential studies, as required.
• Coordinate and oversee the site selection process, identifying potential sites and investigators, conducting initial site quality risk assessments, and, when necessary, performing Site Qualification Visits to evaluate suitability and quality risk
• Ensure timely submission of required applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, supports the delivery of study submissions to Regulatory Authorities, in line with local regulations.
• Prepare accurate country-level financial agreements and maintain up-to-date study budgets within the clinical financial system, ensuring regular checks and alignment with input from the Director, SMM or Director, Country Head and Clinical Finance reporting function, as appropriate.
• Ensure the set-up and ongoing management of studies within CTMS, electronic Trial Master File (eTMF), study finance systems, and any other tools or local platforms necessary to meet countryspecific laws and requirements.
• Oversee, manage, and coordinate all monitoring activities from site activation to closure, in accordance with Monitoring Plans, and thoroughly review monitoring visit reports, offering support and guidance to monitors.
• Conduct required co-monitoring visits, accompanied site visits, and training visits with study CRAs to ensure quality and consistency.
• Proactively identify risks, facilitate the swift resolution of complex study problems, and escalate as necessary.
• Organize and lead regular, agenda-driven Local Study Team meetings, fostering transparent communication and teamwork.
• Build and maintain positive relationships with Local Study Team members, site staff and global stakeholders to ensure smooth study delivery.
• Report study progress and updates to the Global Study Associate Director, Global Study Team, and SMM/Study Operations Lead, as applicable.
• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment goals.
• Develop, maintain, and review a study-level country risk management plan, managing sites, stakeholders, vendors, and customers to ensure timely risk identification and mitigation.
• Coordinates closely with National Coordinating Investigator or National Lead Investigator on recruitment and other study matters, when applicable.
• Plans and leads National Investigator Meetings in alignment with local codes, as needed.
• Assists with forecasting for study timelines, resource needs, recruitment, budgeting, materials, and investigational product supply.
• Ensures set-up, updating, and access to business-critical systems for activities such as Safety Reporting, Regulatory Submissions, and Clinical Trial Transparency at the country level.
• Ensure accuracy and compliance of all study payments, adhering to local regulations and agreements.
• Participate in the training and coaching of new Local Study Team members, ensuring quality and adherence to ICH-GCP standards and AstraZeneca procedures
• Maintain the study eTMF in an “Inspection Ready” state, ensuring documentation is complete and current.
• Plan and lead audit and regulatory inspection activities, working with the Clinical Quality Associate Director (CQAD) and Quality Assurance teams.
• Contribute insights for process development and ongoing improvement within the organization.
• Keep line managers regularly informed about study status, milestones, key issues, and team performance.
• Ensure full compliance with local policies, codes of ethics, and business practices in all study-related activities.
• Provide feedback on research trends, competing studies, or site/investigator information that can benefit the local market.
• Collaborate with the local Medical Affairs team as needed, for optimal study delivery and scientific quality.
• Actively support SMM initiatives at the local, regional, or global level as agreed with line management
• 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 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.

Education, Qualifications, Skills and Experience

Education and experience

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders. Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies)

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to

• Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management.

Role-Required Skills

• Personal Effectiveness & Drives Accountability in Others
• Learning Agility
• Financial, Technology & Process Competency
• Active Listening, Fluency in written & spoken business-level English
• Act with Integrity & high ethical standards
• Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness
• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time
• Ability to travel nationally/internationally as required
• Valid driving license, if country employment requirement
• Communication & Teamwork - Influencing, Collaboration, Impactful Site conversations
• Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management
• Clinical Study Operations (GCP) & Quality Management - RbQM: Interpreting and implementing the Monitoring Plan, Study site selection & set-up
• Deliver Priorities Results & Impact - Project Management, Recruitment/Retention Planning & Action.

※ 채용 절차법에 따른 고지 사항

1. 제출한서류는채용절차법에따라, 일체반환의무가없습니다.

2. 보훈대상자 및 취업보호대상자는관련법에의거하여우대합니다.

3. 해외여행결격사유가없어야합니다.

4. 본 채용은수시진행으로, 우수인력채용 시 마감될 수 있습니다.

Date Posted

23-4월-2026

Closing Date

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 authorization and employment eligibility verification requirements.

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.