Associate Director, Clinical Research (Open locations)

About AstraZeneca and AstraZeneca Vietnam

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @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.
• 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 crises.
• 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.

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.
• Be part of our growth journey and success story: Join the fastest growing pharmaceutical company in our markets, set up to fuel further growth. Make the most of our assets: our strong heritage, our early investment and commitment in emerging markets, and how we embrace digital and data to transform the patient journey. Go beyond your limits. Welcome failure as a chance to learn. There’s no better place to feel inspired, energised and try new things.
• Learn and grow by embracing diverse opportunities: Experience an organisation where professional development is prized and nurtured. Access the tools and support you need to continuously learn. Then it’s up to each of us to step up, speak up and show what we can do. Take advantage of working in a global business with opportunities to move beyond your role and open international doors. At AstraZeneca, your future is in your own hands.
• Urgently bring our leading pipeline to millions of patients in need: Seize the opportunity to help improve the lives of millions of patients, including in areas where patient needs are often unmet. Work with our transformative pipeline to help bring a variety of high-quality medicines to market – and ensure they are made easily accessible to as many patients as possible.
• Be heard in a culture of local empowerment: AstraZeneca is set up for creativity. We encourage unity and ownership at a local level, with collaboration across the global organisation. We tailor how we work, adapting to our markets and healthcare systems. In our diverse community, every voice is important. Share your ideas and opinions openly. In our speak-up culture, the way we communicate with each other leads to more powerful innovation.

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. Our pioneering spirit drives us to make bold moves that truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, you will have many opportunities to work with new and novel drugs. We foster a mindset of courage where everyone is empowered to innovate and work at pace. Our collaborative environment allows us to build collective wisdom by giving everyone a chance to input.

Join us in our mission to make a meaningful difference for patients around the world! Apply today!

Where can I find out more?

Visit our website www.astrazeneca.vn

Follow us on LinkedIn www.linkedin.com/company/astrazeneca/ and Facebook https://www.facebook.com/AstraZenecaVN

Contact us via recruitment.Vietnam@astrazeneca.com

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 authorisation and employment eligibility verification requirements.