Clinical Data Manager- Fully Remote
SmartIMS Inc. - Tarrytown, NY
Apply NowJob Description
The position will report to the Director of Data Management within Medical, Biostatistical and Design Quality (MBDQ). Duties & Responsibilities:• Conduct Study Preparation Meeting (SPM)• Create and Validate Data Management Report Specifications• Work with Database Engineer to create the EDC database specification• Upload preliminary testing data into database• Conduct User Acceptance Testing (UAT)• Create CRF Completion Guidelines• Create and sign-off on the Data Management Plan (DMP)• Drive the use of data standards (i.e., CDISC)• Participate in Study Element Team Meetings• Train end users on eDC system• Grant User Access for eDC system• Adds and/or updates external users'' ids in GAMA• Contributes to departmental process improvement initiatives Required Knowledge/Skills, Education, and Experience:• Master''s degree in a science related field• At least three (5) years data management and/or related work experience in a medical device or pharmaceutical industry/company• Working knowledge within areas of Good Clinical Practices, Good Clinical Data Management Practices, Design and Conduct of Clinical Trials/Studies, and related regulatory requirements and terminology• Experience working within a Clinical EDC system (e.g., OpenClincia, Medrio, Medidata Rave)• Exposure to clinical data coding classification systems, e.g., MedDRA, LOINC, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository• Programming knowledge Python or R is desired• Strong interpersonal, organizational, and communication skills• Excellent attention to detail and problem-solving skills• Ability to work effectively work in a team setting - provided by Dice
Created: 2024-05-04