Apex Systems Inc
EDC Specialist\r\r\r\rPosition Review\r\r\r\r? In charge of developing EDC studies (including eCRF design, EDC display\r\ractions, edit checks and EDC reports).\r\r? In charge of update(s) in EDC studies, their development and their impact on\r\rthe system.\r\r? Communication to the study team members and the sponsor regarding EDC\r\rset-up issues.\r\r\r\rC. Key Responsibilities\r\r\r\r? eCRF design ascertaining the data collection requirements of the study through\r\rreview of the protocol and other supporting documentation in collaboration with\r\rthe Lead CDM/ Senior Manager CDM.\r\r? The CDM EDC Specialist is responsible per study for\r\r? Requesting EDC server\r\r? Reviewing the EDC Specifications\r\r? Drafting and integrating the Web Service Specifications in the EDC\r\rSpecifications (if there are web services)\r\r? Designing the EDC system (e.g.; general configuration, eCRF, profiles)\r\r? Creating edit-checks (and other actions) included in the Data Validation\r\rPlan in collaboration with a Lead CDM/ Senior Manager, CDM\r\r? Creating on-line listings and reports as agreed with the sponsor\r\r? Developing study related key documentation according to standard\r\roperating procedures\r\r? Releasing the EDC system\r\r? Maintaining the study-specific EDC system implementation according to\r\rsponsor requests (including amendments)\r\r? Ensuring that the EDC system is decommissioned when the study has\r\rbeen completed\r\r? Perform tasks in accordance with IDDI standard operating procedures.\r\r\r\rD. Education & Training\r\r\r\rFormal education required: University degree in health related field or\r\rcomputer science or equivalent experience.\r\rOther required courses: GCP training.\r\r\r\rE. Experience & Key Competencies\r\r? Experience in clinical data management\r\r? Advanced database management skills\r\r? Good knowledge and experience in EDC development
Apex Systems Inc
Website : https://www.apexlifesciences.com/
Apex Life Sciences is a division of the 3rd largest clinical/scientific staffing and services firm in the U.S. We match top scientific, engineering, and clinical research professionals at all career levels for contract, contract-to-hire, and direct hire opportunities.