Local Study Associate Director

**LOCAL STUDY ASSOCIATE DIRECTOR**

**About AstraZeneca and AstraZeneca Vietnam**

**AstraZeneca**

**AstraZeneca Vietnam**

As a Foreign Invested Enterprise with over 600 members, AstraZeneca is investing into Vietnam 360 million USD from 2020 to 2030 with a focus on reducing the burdens of non-communicable diseases, developing local talent, and uplifting the domestic biopharmaceutical R&D and manufacturing capabilities.

Over the last three decades accompanying Vietnam’s sustainable development, AstraZeneca has run several impactful programmes in collaboration with the Government, Ministry of Health and healthcare partners to promote disease awareness, prevention and early detection. In recent years, AstraZeneca Vietnam has received several certificates of merit from the Prime Minister and Minister of Health, for excellent contributions to Vietnam’s vaccine diplomacy, fight against COVID-19 and advancement of cancer treatment and disease awareness. The company has also been recognized among Vietnam’s Top 100 Best Places to Work (2018 - 2024) with various other industry awards from BritCham, EuroCham, and government agencies.

**What you’ll do**

Introduction to role:
Are you ready to lead and inspire? As a Local Study Associate Director, you'll spearhead Local Study Teams at the country level, ensuring clinical studies are delivered on time, within budget, and in compliance with AstraZeneca's procedural documents, international guidelines like ICH-GCP, and local regulations. Your leadership will be pivotal in site monitoring, documentation archiving, and maintaining high standards across all study components. With varying internal titles based on experience, this role offers growth opportunities for those who excel in performance and mentorship.

**Typical Accountabilities**:
Take charge of study commitments within the country, ensuring timely delivery of high-quality data.
- Lead Local Study Teams consisting of CRAs and CSAs for assigned studies.
- Optimize team performance while ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
- Conduct clinical and operational feasibility assessments for potential studies.
- Coordinate site selection by identifying potential sites/investigators and conducting Site Qualification Visits.
- Prepare and maintain accurate study budgets and agreements.
- Oversee monitoring activities from site activation to study closure.
- Develop patient recruitment strategies and maintain communication with investigators.
- Manage risks and resolve complex study issues proactively.
- Organize regular Local Study Team meetings and foster good relationships with team members and stakeholders.
- Contribute to process development and improvement initiatives.

**Education, Qualifications, Skills and Experience**

**Essential**
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Excellent organisational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent attention to details.
- Excellent knowledge of spoken and written English.
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
- Ability to travel nationally and internationally as required.

**Desirable**:

- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Good knowledge of the Drug Development Process.
- Excellent understanding of the Clinical Study Process including monitoring.
- Very good understanding of the Study Drug Handling Process and the Data Management Process.
- Integrity and high ethical standards.
- Good analytical skills.
- Good resource management skills.
- Good decision making and delegation skills.
- Good financial management skills.
- Basic change management skills.
- Basic coaching skills.
- Basic ability in handling crisis situations.
- Good intercultural awareness.

**Why AstraZeneca?**

**Be bold and make a powerful impact**:AstraZeneca is a world-leading business where standards are high and challenges complex, but also a collective where we build, support and motivate each other. This unique combination of strong expectation and empowerment invites you to improve how our markets work and make your individual mark. Here, you can follow your ambitions with full confidence. As part of a responsible, value-led business with a strong sustainability agenda, you can also help impact the future beyond business projects.

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