職位描述
General Summary?The Clinical System Designer uses technical, industry and interpersonal skills to program the data entry screens, edit check programs, reports, integrations and to develop and maintain programs required for handling external vendor data. ?The Designer also manages and supports the delivery of the full clinical data management system, including the edit check programs, data integrations, reports, and any other programs required for collection, management and reporting of clinical trialdata.Accountabilities?Understanding the requirements, capabilities and limitations of at least one clinical database management system ?Assist with review of design and assembly of data entry screens by: ?Providing comments on data entry screens ?Assisting with complex data entry screen programming ?Assume responsibility for the edit check programming by: ?Reviewing Edit Check Plans and providing comments ?Assembling edit programs from the appropriate library ?Modifying library edit programs to meet trial-specific requirements ?Programming trial-specific edit programs ? Assume responsibility for report and program development by: ?Contributing to Custom Report Specification creation ?Programming Custom Reports and Programs to meet with requirements of the trial ?Testing that output of Custom Reports and Programs meet the requirements ? Understand and contribute to the management of trial deliverables, scope and resource allocation by: ?Using available and appropriate reports to calculate metrics ?Tracking and communicating metrics to the project team and functional management ?Actively participating in internal meetings ?Providing constructive feedback to peers, team leads and managers, and functional management ? Fulfill all administrative requirements of the position including: ?Timely and accurate completion of timesheets ?Creation and maintenance of yearly goals ?Remaining current with SOP review and required training ? Create and promote a positive work environment ? Develop a strong understanding of industry-related practices ? Contribute to management of external data by ? Liaising with the vendor to ensure timely agreement and approval of the Data Transfer Specifications ? Create and maintain the external data handling instructions and import program specifications ? Receive and manage regular imports of data as specified in the contract ?Understand how to test components of at least two clinical database management systems ?Assuming responsibility for the creation and maintenance of technical test plansQualifications?Degree in a technology or clinical discipline?Excellent written and oral communication skills. ?Read, write and speak fluent English and Mandarin required ?Extensive programming experience in at least one widely accepted clinical data management system preferred ?1-3 years working in a pharmaceutical or CRO environment with at least 1 years working directly with industry standard Clinical System Development systems (Oracle Clinical, InForm, Rave, DataLabs, OpenClinica, Clintrial, eData Management) or electronic data capture (EDC) software.
