Senior Clinical Database Programmer |O|268

My research opens up new medical possibilities. And I do it Search Jobs Search Jobs Keyword: Location: Radius: Unit MILES KM Senior Clinical Database Programmer India, Remote Job ID R0000XXXXXX+ Category Data Management About this Role Key Accountabilities: Accountability Supporting Activities Set-Up, Maintain, Revise, Close-Out Electronic Data Capture Systems • Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based • (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable. • Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements. • Accountable for first time quality on all deliverables. • Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines. • Provide input into and negotiate database setup timelines. Ensure that timelines are adhered to by: • Actively assume activities on a project as required. • Monitor project resourcing and identify changes in scope. • Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality. • Interact with Sponsors and Data Management Leaders as the key contact with regard to programming related issues. • Provide technical support and advice to the internal team. • Ability to lead and support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies on multiple projects simultaneously. • Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required). Support Projects & Technologies • Assist in providing technical solutions to internal or external/client enquires. • Support to build or integrate systems within the GDO Area. Execute other programming languages and processes within the GDO area. (e.g. Clinical Trial Management System, Safety Systems, Coding Systems) • Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized Documentation • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams. • Maintain technical documentation that is applicable to the Clinical Database. Support Initiatives • Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes. • Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies Act as a mentor and/or SME • Provide relevant training and mentorship to staff and project teams as appropriate. • Assist project teams in the resolution of problems encountered in the conduct of their daily work. • Assist in providing technical solutions to internal or external client enquires. • Maintain and expand local and international regulatory knowledge within the clinical industry. Skills: • Excellent English written and oral communication skills. • Demonstrate ability to learn new systems and function in an evolving technical environment. • Attention to detail. • Ability to work together with a team (including international teams as required) as well as independently. • Work effectively in a quality-focused environment. • Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change. • Business/Operational skills that include customer focus, commitment to quality management and problem solving. • Good business awareness/business development skills (including financial awareness). • Work effectively in a quality-focused environment. • Strong leadership ability. • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial. • Demonstrate commitment to refine quality processes. Knowledge and Experience: • Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java). • Experience working with at least one system used within the Clinical Trial process (e.g. SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting). • Relevant Clinical Trial industry experience. • Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. Education: • Bachelor’s degree (or equivalent) in a relevant science discipline is preferred or equivalent work experience #LI-REMOTE Share this job Explore what makes Parexel's work culture unique JOBS FOR YOU - Australia, Remote You currently have no saved jobs to view. Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page. 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