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Associate Director, Clinical Research

2 months ago

Ho Chi Minh City, Vietnam AstraZeneca Full time

**Associate Director, Clinical Research - HCM**

**About AstraZeneca and AstraZeneca Vietnam**

AstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines. At AstraZeneca, science and patients are at the heart of everything we do. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Established in 1994, AstraZeneca Vietnam has come a long way in 27 years of advancing Vietnam's healthcare. We change lives through innovative science with $25mil in R&D investment (2020 - 2024); 40 ongoing clinical trials with 2800+ patients; 44 partnered hospitals and 14 medicines involved in trials. We have built strong public-private partnerships for sustainability and healthcare access through many programs and activities such as Healthy Lung, Young Health Program, Careme, Giá Như, Health System Sustainability & Resilience, Green Energy for Health, Response to Covid-19.

We have gained some recognition for our efforts from the Minister of Health's Certificates of Merits for outstanding contributions to advancing cancer treatment (2019) and exceptional contributions to Vietnam’s fight against COVID-19 (2020); BritCham 2021 Awards for Contributions to healthcare and 25+ years of service in Vietnam; Ho Chi Minh Communist Youth Union’s Medal and Certificate of Merit for contributions to youths (2021); Excellent Leadership - Visionary Leader Award (2021); HR Excellence - Workplace Culture Award (2021) and Vietnam's Top 100 Places to Work Award (2018 - 2020).

**What you’ll do**

**Short role description**

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 is responsible for line managing dedicated group(s) of staff such as Clinical Research Associates (CRAs) and/or Clinical Study Administrators (CSAs) and is responsible for planning and utilization of staff resources, objective setting and performance follow-up.

As assigned, the ADCR is responsible for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived, as agreed locally.

In some countries a ADCR may also take responsibilities as Local Study Associate Director (LSAD) if required and agreed with the (Senior) Director, Country Head.

**Typical Accountabilities**
- Leadership of dedicated group, building the team spirit, developing team style and behaviour.
- 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 IDP process.
- Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed.
- Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
- Contributes to efficient SMM organisation and its functioning at country level by working closely with 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 the 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 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 the 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
- If ADCR takes a role as LSAD, please refer to the corresponding Job description_.

**Education, Qualifications, Skills and Experience**

**Essential**
- 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 a

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