Study Contracts Manager

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 – 2024) with various other industry awards from BritCham, EuroCham, and government agencies.

What you’ll do

The Study Contract Manager (SCM) play an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices.

SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.

Typical Accountabilities:

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value. 
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audit activities.
• Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology and security.
• Ensure that all contracts are included in the TMF

Upon local decision, additional responsibilities may include*:

• Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences.
• Support preparation and negotiation of a Local Master Service Agreement
• Contribute to process improvements, knowledge transfer and best practice sharing.

*Note: Additional responsibilities may be adjusted locally

Education, Qualifications, Skills and Experience

Essential

• Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills

Desirable

• Ability to work in an environment of remote collaborators.
• Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry
• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Familiar with risk-based monitoring approach including remote monitoring.
• Good cultural awareness.
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas

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.

So, what’s next?

If you’re curious to know more then please take initiative to recruitment.Vietnam@astrazeneca.com. We encourage your application.

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