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Arbetsbeskrivning
Job description
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.
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.
Qualifications
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.
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
Application
2020-10-01, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.
For more information: Eleonor Ehrman, Consultant Manager: +46 733 434109
About the company
Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.
Kontaktpersoner på detta företaget
Daniella Petersen
Cecilia Mannheimer
Emelie Özgun
Pontus Adolfsson
Konsultchef Katja Löfström
Maria Johansson
Maria Öhlander
072-9889604
Jonna Blom
Emelie Özgun
0729889603
Konsultchef Camilo Garcia Sanchez
0729889044