The Malaghan Institute of Medical Research is Aotearoa New Zealand’s leading independent biomedical research institute, with a focus on breakthrough discoveries in immunology and immunotherapy. In the wake of the current pandemic, one of our key areas of research and discovery currently lies in infectious diseases.
We are working together with Victoria University of Wellington and the University of Otago to form the Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo (VAANZ) working on a COVID-19 vaccine evaluation and development platform to assess domestic and international vaccine candidates in pre-clinical models and human trials.
We are seeking an experienced and highly organised Clinical Programme Manager (CPM) to coordinate the implementation and management of a multi-site clinical study of COVID-19 vaccination outcomes. As our new CPM, you will manage operations for the study, including protocol documents and study tools, monitoring enrolment and overall study progress, site communications, and sample management.
- BS/BA in a scientific, life sciences field,or BS with equivalent clinical research work experience.
- Masters degree in science or public health-related areas desirable
Experience and skills:
- Related experience in clinical research – e.g. study coordination, data management, study nurse or physician.
- Minimum of 3-5 years experience in managing studies, writing protocol documents, overseeing study implementation, and coordinating sample management.
- Experience with vaccine clinical research trials, clinical laboratory testing desirable.
- Strong proficiency in GCP
- Proven track record of meeting clinical trials milestones, timelines and working closely with clinical trial sites to ensure objectives are met.
Please read out more about the position duties and apply via this link: https://malaghannz.bamboohr.com/jobs/view.php?id=53&source=aWQ9OQ%3D%3D
Applications close Friday 19 March 5pm.
Do you have expertise in, and passion for, Clinical Research? Would you like to apply your expertise to impact the effectiveness and medication of products in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
We’re investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success. Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.
We are a hard-working, fun, fast paced, encouraging, cake-loving (with free gym access) team! We are continuously evolving and adapting to build new and better ways of working across clinical research and development. We want to support each other to be as efficient as possible to drive work life balance. We are undergoing expansion and with so many roles locally and globally, we provide opportunities to drive your development and growth your way. The team has grown by 60% in just 2020 alone, and still growing. Our pipeline and projects are continuously growing, and we want you to join us!
What you’ll do
You are a self-motivated, proactive, and passionate individual focused on delivering quality outcomes in a fast-paced environment. The new Clinical Research Associate (S/CRA), initially on a contract basis, will be involved in effective site management across a number of high-profile studies as well as all aspects of the study from preparation, initiation, monitoring, and closure.
To be successful in this role you will have good knowledge of Clinical Study Management across monitoring, study drug handling and data management. You will ideally have experience working in a similar capacity, have excellent knowledge of international guidelines ICH-GCP, relevant local regulations and a basic understanding of the drug development process.
Essential for the role
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH‐GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Desirable for the role
- Ability to work in an environment of remote collaborators.
- 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.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have seats available and we hope it’s yours.
- If you’re curious to know more then please reach out to Daniel Kim. We welcome your application
Where can I find out more?
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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.
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