Associate Director, Clinical Research

**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 - 2023) with various other industry awards from BritCham, EuroCham, and government agencies.

**What you’ll do**

**_ Introduction to the role_**

The Associate Director Clinical Research (ADCR) is responsible for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources and timelines, complying with AZ Procedural Documents, international guidelines such as ICH-GCP, as well as relevant local regulations. The ADCR will line manage dedicated groups of staff such as Clinical Research Associates (CRAs) and/or Clinical Study Administrators (CSAs), ensuring effective planning and utilization of staff resources, objective setting, and performance follow-up. Additionally, the ADCR ensures that study sites are identified, qualified, set up, initiated, monitored, closed, and documentation archived as agreed locally. In some countries, the ADCR may also take on responsibilities as Local Study Associate Director (LSAD) if required and agreed with the (Senior) Director, Country Head.

**Typical Accountabilities**:

- Leadership of dedicated group, building team spirit, developing team style and behavior.
- Ensures adequate resources for the studies assigned.
- Ensures that the workload of direct reports is adequate.
- Development and performance management of direct reports.
- Ensures that direct reports have development and training plans according to the IDP process.
- Coaches direct reports regularly and organizes coaching with external providers if needed.
- Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with the responsible (Senior) Director, Country Head, and local HRBP.
- Contributes to efficient SMM organization and its functioning at the country level by working closely with the responsible (Senior) Director, Country Head.
- Contributes to high-quality feasibility work.
- Supports successful delivery of SMM study delivery country-level targets to plan, with speed and quality.
- Contributes to the quality improvement of study processes and other procedures.
- Ensures all systems are continuously updated.
- Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
- Provides direction to CRAs and CSAs on major study commitments including resolving any key issues identified.
- Ensures that study activities at the country level comply with local policies and code of ethics.
- Reviews monitoring visit reports of direct reports in line with AZ SOPs.
- Reviews accompanied site visits/co-monitoring visits/training visits/QC visits performed to direct reports in line with local QC plans.
- Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development. Ongoing communication with Functional Service Providers, including directions and feedback on insourced/outsourced work.

**_ Essential Skills/Experience_**
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
- Minimum 4 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
- Excellent interpersonal skills.
- Manage change with a positive approach for self, team, and business. Sees change as an opportunity to improve performance and add value to business.
- Project management experience.
- Excellent organizational, analytical, influencing, and negotiation skills.
- Excellent presentation and communication skills, verbal and written.
- Excellent knowledge of spoken and written English.
- Good ability to learn and adapt to work with IT systems.
- Ability for national travel, if applicable.

**Education, Qualifications, Skills and Experience**:
**Desirable Skills/Experience**
- Good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
- Excellent knowledge of the Monitoring Process.
- Good understanding of the Study Drug Handling Process and the Data Management Process.
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