Nonclinical Send Data Associate
hace 8 meses
Are you ready to harness the power of data for growth? In AstraZeneca, we are seeking data operatives to provide technical expertise for SEND data from nonclinical studies. This role is crucial in meeting health authority requirements and maximizing the opportunities these data present. Join us and lead the way for a new breed of solutions-oriented regulators
**Accountabilities**:
As a Nonclinical SEND Data Associate, you will provide support across nonclinical functional areas, promoting and enforcing the use of nonclinical data standards. You will maintain metadata libraries, review and assess the impact of newly released and updated data standards, and communicate AZ data requirements to external vendors. You will also be responsible for quality validation and management of nonclinical datasets, training internal customers, assisting in warehousing and visualization activities, and ensuring submission-ready datasets are produced.
**Essential **S**kills/Experience**:
- Three to five years related experience in a scientific environment
- Knowledge of CDISC standards
- Understanding of nonclinical study designs, data and documentation
- Knowledge of regulatory guidelines and industry standards (FDA, ICH/GLP, PhUSE)
- Experience in data process builds
- Experience with LIMS and SEND solution software
- Bachelor’s degree (B.A./B.S.) or equivalent in a scientific or related discipline
- Ability to communicate effectively (written and spoken) in English
**Desirable **S**kills/Experience**:
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca's Biopharmaceuticals R&D, we are part of the solution, turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.
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