EDC Specialist, Clinical Applications and Standards

We are currently looking for a highly motivated EDC Specialist. Would you like to contribute directly to AZ’s strategy of growth through Innovation? Then please Join us at our R&D site in Gothenburg, Sweden. For further details around this position you are welcome to contact Jenny Lundkvist. The 12-months consulting assignment will start as soon as possible with possibility of extension. Welcome with your application no later than 2th of October.



Om tjänsten
EDC Specialist is responsible for the development, implementation and maintenance of the systems and applications supporting Drug Development across multiple therapeutic areas. This position supports tool development activities that support the CA&S and Data Management. EDC Specialist, also responsible for all technical aspects of database build, edit checks, custom functions and report programming, as part of inhouse study build activities. Supports DM initiatives that may include outsourced trials, CROs and off-shore partners. Reports directly to Associate Director Clinical Applications and Standards.

Major Duties and Responsibilities:
• Serves as a subject matter expert for escalation and provides expertise for problem-solving with clinical database technology, capabilities and functionality.
• Develops Database design specifications/definitions in consultation with data management, statistics and programming.
• Collaborates/updates global library as appropriate per governance directives and according to best practices.
• Designs/creates and tests clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports.
• Verifies completeness of study deliverables prior to release from the group
• Performs peer review for the studies build by other programmer.
• Maintains all required study documentation.
• Conduct training sessions on EDC database use for internal users.
• Assist in all areas of DM process improvements and Standards (SDTM / CDASH).
• Reviews/SOPs, Guidelines and Instructions to promote consistency.
• Identifies and understands the need for standardization and takes initiative to innovate and help improve departmental efficiency.
• Develops technical problem solving solutions and assists in the development of new technologies with RDIS, as appropriate.
• Coordinates user access and study level access in DM applications.
• Provides technical assistance and training to technical / non-technical personnel.
• Consults and provides input into system validation efforts including tool maintenance activities.
• Perform all other related duties as assigned.

Vem är du?
Education:
• BA / BS computer science/information technology or life sciences degree and/or equivalent experience.
Experience:
• Clinical programming experience is required.
• Custom Solutions development experience is preferred.
• Proficient computer skills across multiple applications.

Special Skills/Abilities:
• Good knowledge of Medidata suite of applications preferred (e.g. Medidata Coder, Lab Administration Module, Targeted Source Data Verification (TSDV), Safety Gateway, Patient Cloud).
• Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required.
• Expertise with reporting tools; Business Objects, J-Review, and/or Spotfire are preferred.
• Knowledge of industry standards; CDISC-SDTM/CDASH preferred.
• Experience with external data handling of study data preferred.
• Experience with clinical dictionaries; MedDRA and WHO dictionaries are preferred.

Om verksamheten
At AstraZeneca, we turn ideas into life changing medicines. We win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do.


Are you ready to make a difference?
Send in your application, and we’ll make it happen together.