EDC Specialist, Clinical Applications and Standards

POSITION SUMMARY:
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.


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.

REQUIREMENTS/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.

 

ABOUT ALTEN
ALTEN is a consulting company that develops and delivers expertise for world-leading companies with consultants in technology, IT and biochemistry. We are located in over 28 countries, have our headquarter in Paris and have more than 37 200 employees, of which 88 percent are engineers. In Sweden, we have over 1 700 employees and work from offices in twelve locations. Our clients are found in industries such as Automotive, Energy, Telecom, Industry, Aerospace & Defence and Life Science, where our consultants operate throughout the product development chain.

Welcome to read more about us at alten.se or please contact Oscar Sundell, Business Manager at Oscar.Sundell@alten.se.