Local Study Associate Director (Biopharmaceutical)

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.

​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.

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. 전자우편으로제출한서류는채용절차법에따라, 일체반환의무가없습니다.

2. 보훈대상자 및 취업보호대상자는관련법에의거하여우대합니다.

3. 해외여행결격사유가없어야합니다.

4. 본 채용은수시진행으로, 우수인력채용 시 마감될 수 있습니다.

아스트라제네카의 SMM (Site Management & Monitoring) 부서는 아스트라제네카 본사의 연구개발 산하에 있는 임상시험 수행부서로서, 각 나라에서 해당 임상시험이 잘 수행될 수 있도록 관리합니다. 아스트라제네카의 SMM 부서는 글로벌 본사의 치료분야의 다각화 전략에 따라 항암제 분야와 비-항암제 분야로 부서를 분리하였으며, 이에 최근 한국 아스트라제네카 SMM 부서 역시 두개로 분리되었으며, 비-항암제 분야는 SMM BioPharma 라는 이름으로 새로운 리더십팀과 함께 2023년에 출범하였습니다. 한국 아스트라제네카 SMM BioPharma 부서는, 비-항암제 분야의 파이프라인 확장을 지원하기 위해 현재 새로운 연구를 한국에 유치하고 수행하기 위해 많은 인력이 필요하며, 앞으로의 성장과 발전이 기대되는 조직입니다. 미래가 더욱 기대되는 한국 아스트라제네카 SMM BioPharma 부서에서 임상시험전문가로 성장할 정규직 Study Start-Up Associate Director (SSU-AD)를 채용하오니 많은 지원 바랍니다.

Date Posted

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.