Clinical Database Developer I

JOB TITLE: Clinical Database Developer I

CAREER LEVEL: C

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

ABOUT OUR IT TEAM

It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.

About the role

Creates the Clinical Database Development (CDD) deliverables on assigned clinical studies. Responsible for the quality of CDD deliverables following standards, Standard Operating Procedures (SOPs) and Guidelines. Maintains Business Continuity for CDD processes and standards including integrity of the clinical database for the relevant studies.

Typical Accountabilities

• Responsible with supervision for the timely and quality creation of electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies

• Responsible with supervision for the timely and quality creation of data entry screens according to the approved annotated Case Report Form (CRF) for paper studies

• Responsible with supervision for the timely and quality creation of the Design, build and testing of clinical databases according to SOPs and Guidelines

• Responsible with supervision for the timely and quality programming of field derivations, edit checks, consistency checks, validations, procedures and rules

• Responsible with supervision for the timely and quality programming of data extraction programs

• Responsible with supervision for the timely and quality development of study reporting and visualization environment which includes CRF and non-CRF (loaded) data in addition to redefining collected data to required reporting format.

• Responsible with supervision for the timely and quality creation of study level documentation for all databases used in data management

• Responsible with supervision for study database documentation maintenance in the electronic Trial Master File (eTMF)

• Responsible with supervision for the timely and quality system testing and Quality Control (QC) of specified work

• Participates in projects to automate, simplify and innovate in order to ensure that the team is industry leading.

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree, preferably in computing or scientific field

• Database development experience in the pharmaceutical industry working with clinical trial data.

• Practical experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS

• Excellent written and verbal communication skills

• Ability to work in a distributed team environment

• Good analytical skills and high attention to detail.

Desirable

• Knowledge of clinical and pharmaceutical drug development process and Clinical trials

• Understanding of data standards (CDISC) and practices Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through inspiration

• Experience with programming languages Python, APEX, PL SQL, XML, Java an advantage

• Experience with Medidata’s Rave Study Build

• Experience in Medidata Rave Custom Functions

• Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau.

Key Relationships to reach solutions

Internal (to AZ or team)

Clinical Data Management Teams

Statistical and Clinical Programmers

Statistician

Clinical Colleagues

Clinical Quality Assurance and Compliance

Core Team/Extended Study Team Members

Patient Safety Team

Biometric operations

WHY JOIN US?

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.