CDA II (BB-6C0FE)
Encontrado en: Neuvoo AR
JOB SUMMARYThis position is responsible for assisting in all clinical data management activities required for clinical trials with proficiency and by providing guidance to other Clinical Data Associates (CDAs).
•Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).•Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).•Creates and enters test data for User Acceptance Testing (UAT)•Performs User Acceptance Testing (UAT) for data entry screens, edits and assigned data review listings, all different roles used in the study.•Receives and enters lab normal ranges.•Completes and submits Clinical Database Management System (CDMS)- specific access forms and/or spreadsheets.•Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries correctly and re-queries where appropriate.•For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the Case Report Forms (CRFs) and database accordingly. Submits copies of the DCFs to sponsors as necessary.•For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.•For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.•For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems.•Creates electronic storage media per SOPs for Electronic Data Capture (EDC) studies.•Participates in internal meetings and internal/external audits as required.•Files documentation in the Data Management Study File (DMSF).•Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).•Creates and enters test data for Standard Data Tabulation Model (SDTM) test data.•Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.•May coordinate the work of CDAs assigned to the project.•May provide training on data management activities and systems.•Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.•Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.•Runs data cleaning and/or status reports.•Performs Serious Adverse Event (SAE) reconciliations.•Understands the coding process.•Understands the purpose of interim, dry run, data cut.
QUALIFICATION REQUIREMENTS BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.Experience with DM practices and relational database management software systems preferred.Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred.Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.Work experience in clinical research, drug development, data management, or other healthcare environment preferredFamiliarity with medical terminology.Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team.Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).
calendar_todayhace 6 días
work Syneos Health