Typical Accountabilities: 

• Ensure the Data Review tool is fit for purpose through set-up, maintenance and close-out of study  according to agreed Best Practice procedures  – to allow for handling of safety data and review for medical completeness and medical accuracy 

• Generate high quality Clinical/Safety Data Review reports that are aligned for TRISARC members and the Global Therapeutic Areas 

• Work with data outputs (i.e. generate reports, complex data) from multiple sources such as the clinical database, external labs, ECG providers, and other safety vendors as appropriate.  

• Provide input into non-drug project work including training activities, continuous improvement,  and development of procedures as needed 

• Work closely with IT and R&D Information functions to align on tool maintenance and tool improvement; provide customer feedback from the end user (TRISARC Safety Specialists, Study Physicians, Clinical Scientists) 

• Take on ad-hoc tasks as assigned by the TRISARC Leadership team members (e.g., capacity reports, business intelligence) 

Education, Qualifications, Skills and Experience 

Essential: 

• University degree in related discipline 

• Minimum one year of experience working on clinical studies in the Biotech/Pharma/CRO industry or equivalent 

• Proven organizational and analytical skills 

• Understanding of the clinical study and drug development process  

• Knowledge of ICH/GCP Guidelines  

• Knowledge of SAE reporting requirements 

• Proven ability to prioritize and manage multiple tasks with conflicting deadlines 

• Ability to work independently, as well as in a team environment 

• Independently designing and planning own work 

• Managing change and uncertainty for self 

• Computer proficiency including Microsoft Outlook, Excel and Microsoft Power Platform 

• Excellent knowledge of spoken and written English 

• Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information 

• Exhibit of AZ Values and Behaviours 

Desirable : 

• Relevant industry or health care experience 

• Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas 

• Good understanding of clinical data flow 

• Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information 

• Ability to develop advanced computer skills to increase efficiency in day to day tasks 

• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities Experience using data review tools such as JReview, JMP Clinical, or Spotfire