Clinical Database Developer/ Certified RAVE Developer
The Clinical Database Developer/Certified RAVE Developer coordinates the Clinical Database Development (CDD) activities for assigned clinical studies. This position requires a deep understanding of CDD processes, standards and technology. As a member of the Global Study Team (GST), will ensure all CCD activities follow standards and meet data quality and integrity for business continuity.
- Coordinates 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
- Coordinates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
- Communicates with data management, medical, analysis and reporting and study management teams throughout all study start up activities to ensure team needs are understood and met.
- Coordinates design, build and testing of clinical databases according to Standard Operating Procedures (SOPs) and guidelines
- Coordinates Programming of field derivations, edit checks, consistency checks, validations, procedures and rules and for writing data extraction programs
- Coordinates the 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.
- Performs peer review
- Ensures the timeliness and quality of study level documentation for all databases used in data management
- Accountable for study database documentation maintenance in the electronic Trial Master File (eTMF)
- Works in collaboration with the GST to define all technical elements of the Data Management Plan
- Accountable for timely system testing and Quality Control (QC) of specified activities
- May assist in maintaining the Clinical Data Management Systems global and program libraries
- May be required to undertake programming and testing tasks as needed
- Participates in projects to automate, simplify and innovate in order to ensure that the team is industry leading
- Mentor and train Database Developers
- Bachelor's degree, preferably in computing or scientific area
- 3 to 7 years database development experience in the pharmaceutical industry working with clinical trial data
- Experience with Medidata's Rave Study Build and Custom Functions
- Practical experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, R, Python
- Excellent written and verbal communication skills, organized and ability to lead tasks from concept to delivery using strong planning and project management skills
- Solid understanding of clinical data system design / development / validation and system interoperability.
- Thrives in working independently without close supervision
- Excellent organizational and analytical skills and high attention to detail
- Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement
- Experience or knowledge of Rave Safety Gateway, TSDV and programming languages Python, APEX, PL SQL, XML, Java is an advantage
- Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau is desirable
About AstraZeneca Canada:
Our purpose is bold and so is our approach. Becoming a more agile and innovative company means creating a vibrant, dynamic culture where we celebrate entrepreneurial thinking and act quickly to inspire change. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new insights and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us at our great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 6 years: https://reviews.canadastop100.com/top-employer-astrazeneca-canada
- Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
- Learn more about our culture: https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
Are you interested in working at AZ? Apply today!
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.