Assistant clinical data coord
About the role
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Under supervision of more experienced Data Management Personnel and inaccordance with project specific timelines,to perform basic data managementactivities to ensure the generation of accurate, complete, and consistent clinicaldatabases. To fulfill his/her job responsibilities in accordance with Good ClinicalPractices (GCPs}, ICON Standard Operating Procedures (SOPs), WorkingProcedures (WPs}, Study Specific Procedures (SSPs). International Committee onHarmonization (ICH) Guidelines,and all applicable laws and regulations.
JOB FUNCTIONS/RESPONSIBILITIES
*Recognize. exemplify and adhere to ICON's values which centersaround our commitment to People, Clients and Performance
• *As a member of staff,the employee is expected to embrace and contributeto our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Travel (Up to 5%) domestic and/or international
• *Read,ensure understanding and adhere to all assigned ICON SOPs andworking procedures
• *Ensure all work performed is of high quality , compliant with Good ClinicalPractice, ICH Guidelines and all applicablelaws and regulations
• *Complete all assigned training and courses in the ICON TrainingManagement system (i earn); ensuring that mandatory courses areall completed before the designated date and that the required systemspecific training has been completed for current studies
• *Record all billable and non-billable time in the appropriate timesheetmanagement system (e.g. Planview™)
• *Review CRF/eCRF data for completeness, accuracy, and consistency viacomputerized edits and manual data checks
• *Generate and close/resolve (as appropriate) data queries
• *Freeze and/or lock eCRFs (as appropriate) within the Electronic Data CaptureSystem
• *Assist with creation and maintenance of study files and other appropriate studydocumentation
• *Perform Quality Review of clinical data
• *Perform other project activities as required in order to ensure thatstudy timelines are met (for example,filing and archiving of studydocumentat ion,dispatching of queries to investigator sites forresolution, etc.)
• *As required,communicate effectively with the project team, ClinicalDataLead and Project Manager
• To undertake other reasonably related duties as may be assigned fromtime to time
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
• To perform this job successfully, an individual must be able toperform each essential duty satisfactorily. The requirements listed beloware representative of the knowledge, skill, and/or ability required.Reasonable accommodations may be made to enable individuals withdisabilities to perform the essentialfunctions.
• Prior Data Management experience preferred
• Strong written and oral communication skills
• Ability to work within a team environment
• Excellent interpersonal skills
• General computer literacy. Knowledge of database technologies and processes is a plus
• Knowledge of medical terminology is a plus
Academic Requirement:
Bachelor's degree or local equivalent in a scientific or related discipline and/orappropriate experience
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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