Senior Clinical Database Developer I

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Coordinates the Clinical Database Development (CDD) work on assigned clinical studies and may be an expert on CDD processes, standards and technology. Member of the Global Study Team (GST). Responsible to ensure that CDD work you're doing follows standards and meets data quality. Maintains Business Continuity for CDD processes and standards including integrity of the clinical database for the relevant studies.

Key Responsibilities:

Coordinates or programs and ensures timeliness and quality for creation of electronic Case Report Forms (eCRFs) according to protocols and study design specifications for Electronic Data Capture (EDC) studies.
• Coordinates or programs and ensures timeliness and quality for creation of 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 or programs and ensures timeliness and quality for the Design, build and testing of clinical databases according to Standard Operating Procedures (SOPs) and guidelines.
• Coordinates or programs and ensures timeliness and quality for Programming of field derivations, edit checks/custom functions, consistency checks, validations, procedures and rules.
• Coordinates or programs and ensures timeliness and quality for writing data extraction programs.
• Performs peer review.
• Coordinates or programs and ensures timeliness and quality for the development of study reporting and visualization environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format.
• Accountable for the timeliness and quality of study level programming 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
• Responsible for ensuring that system testing and Quality Control (QC) of specified work is completed on time and meets quality standards.
• 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

Education, Experience & Skills:

Bachelor's degree or equivalent experience, preferably in computing or a related field

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

•Clinical trial knowledge

•Experience in Study Build (Study Design & Validation Rule development)

•Good knowledge/understanding of handling the Postproduction changes.

•Must be certified in Medidata Rave SDBE certification.

•Experience in Medidata Rave Custom Functions

•Experience or knowledge of Rave Safety Gateway, TSDV, Coding, inbound/outbound integrations, script utilities & different Rave reports

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

•Excellent written and verbal communication skills organized and ability to lead tasks from concept to delivery.

• Solid grasp of clinical data system design / development / validation and system interoperability.
• Ability to work independently without close supervision.

•Excellent planning and project management skills.
• Proficiency in functioning within a distributed team framework.
• Excellent organizational and analytical skills and high attention to detail
• Experience in other EDC tools (Inform, Veeva) are added advantage. 

Demonstrated knowledge of clinical and pharmaceutical drug development process
• Brand new understanding of data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
• Demonstrated ability to work effectively with external partners.
• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement.

•Experience with programming languages Python, R, PL SQL, XML, Java, or SAS are added advantage. •Experience with reporting environments such as Crystal Reports, Business Objects, Tibco Spotfire, PowerBI or Tableau are added advantage

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