Job Description

The Director, Site Management & Monitoring (DSMM) is responsible for ensuring the successful performance and management of the assigned team, guaranteeing the successful delivery of all clinical interventional studies under the supervision of a Country Head, in accordance with agreed resources, budgets, and timelines. All study activities must comply with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. This role oversees a dedicated group or groups of staff, taking accountability for line management, resource planning and utilization, budget oversight, objective setting, and performance monitoring. The DSMM is also expected to contribute to regional and global initiatives as delegated, providing support to the Country Head as needed. In this role, the DSMM ensures that their team guarantee study site identification, conduct site qualifications and that sites are set up, initiated, monitored, and properly closed, with all study documentation appropriately archived.

Accountabilities for this role include:

• Lead a dedicated team, fostering a cohesive team spirit and shaping a positive, high-performing team culture and professional behaviours.
• Ensure that the team is adequately staffed and that all studies under their supervision are adequately resourced to achieve successful and efficient outcomes, in alignment with (Senior) Director, Country Head.
• Balance and monitor team workload, ensuring assignments are distributed appropriately among direct reports.
• Oversee the development and performance management of direct reports, supporting their growth and effectiveness.
• Ensure that every direct report has an up-to-date development and training plan aligned with the Individual Development Plan (IDP) process.
• Provide ongoing coaching and mentorship to direct reports, arranging additional external coaching opportunities when required.
• Prepare salary and bonus recommendations for direct reports based on performance, in close collaboration with the (Senior) Director, Country Head, and local HR Business Partner.
• Collaborate with the (Senior) Director, Country Head to ensure efficient operations and effective organizational functioning of Site Management & Monitoring (SMM) activities at the country level.
• Contribute expertise to high-quality feasibility assessments for clinical studies. • Oversee the achievement of SMM study delivery targets at the country level, ensuring timely completion with a strong focus on quality, in alignment with (Senior) Director, Country Head.
• Support continuous improvement of study-related processes and procedures to drive quality outcomes.
• Ensure all required systems are consistently maintained and updated for optimal operation.
• Oversee the completeness and timeliness of the electronic Trial Master File (eTMF), ensuring it remains "Inspection Ready".
• Assist the (Senior) Director, Country Head and/or Local Study Associate Directors (LSADs) and study teams in forecasting key elements of clinical studies, including timelines, resources, recruitment, study materials, and drug supply.
• Provide direction and guidance to LSADs and study teams on major study deliverables, proactively addressing and resolving priority issues.
• Support regional SMM initiatives and activities, as needed, in partnership with the (Senior) Director, Country Head.
• Foster strong collaboration with the local Medical Affairs team to ensure functional alignment and compliance.
• Ensure all study operations at the country level conform to local policies and the company’s code of ethics.
• Ensure regulatory tasks and start- up activities related to the studies assigned to the country are accomplished.
• Review and evaluate accompanied site visits, co-monitoring visits, training visits, and Quality Control (QC) visits performed for direct reports, according to local QC plans.
• Conduct accompanied site visits per the local QC plan, using this opportunity to support coaching and continuous development of team members.
• Participate in local regulatory or operational external expert groups as necessary at the country level.

Skills

• Good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
• Excellent knowledge of the Feasibility and Project Management Process.
• Good knowledge of relevant local and international regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Ability to deliver quality according to the requested standards.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Ability to work in an environment of remote collaborators.
• Integrity and high ethical standards.
• Good resource management skills.
• Excellent decision-making skills.
• Good conflict management skills and ability to handle crisis.
• Good interviewing skills – responsibility for attracting, developing and retaining personnel.
• Excellent team building skills.
• Good intercultural awareness.
• Excellent ability to work according to global standards.

Qualifications

• Education: BSc
• Language: Korean and English
• Certifications: GCP
• Work Experience: More than 6 years
• Competencies: TA and Team Management Experience

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3. 해외 여행 결격사유가 없어야 합니다.

4. 본 채용은 수시진행으로, 우수인력 채용 시 마감될 수 있습니다.

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.