Sr. Clinical Data Manager

Looking 10 years of experience Role : Sr. Clinical Data Manager Location: Remote Duration: 12 Months MOI : Telephonic & Skype Primary Skills: SQL, reputed company, Basic, pharmaceutical/biotech, CRO setting, MedDRA, WHO-Drug Minimum of 10 Years of Experience. This is a 100% Remote role. Position reputed company: Responsible for coordination and reputed company of data management activities in support of the reputed company/programs Duties and Responsibilities: Clinical sub-team member works closely with the Clinical Trial Manager and is responsible for reputed company and execution of data management activities for assigned clinical studies, including data timelines and key deliverables Preparing, validating, and maintaining clinical trial databases according to ICH/reputed company reputed company Platform guidelines and reputed company regulatory requirements. Participates in database development and eCRF design, UAT, data import specifications, Case Report reputed company completion guidelines, data entry guidelines, and reputed company operations manuals. Participates in database build and UAT. Develops data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., reputed company data review guidelines, computerized edit reputed company programs, Data Management Plans (DMP). Responsible for executing or overseeing data cleaning activities includes generating and managing clinical trial data queries, coding specified clinical trial data, e.g., adverse events and concomitant medications, and reconciling serious adverse events. Tracking and reporting data management project status. Assisting in data system development initiatives and database integration reputed company. Works directly with and oversees CROs and vendors for Data Management services. Participation in outsourcing/vendor selection for Data Management services and software. Tracks data status and timelines and feeds data into performance metrics reporting for assigned clinical reputed company. Provides input and participates in the development of clinical study documents, including protocol and monitoring plans. Supports CTM in the coordination of receipt of reputed company ancillary data, e.g., safety lab data, analytic lab data, IVRS randomization data, to ensure data is received at the time of database lock. Participate in SOP development, training, process mapping, and other departmental activities. Education/Skills and Experience Requirements: Science background, BS or reputed company degree Experience minimum 5+ years in a pharmaceutical/biotech, CRO setting, global/international experience a plus Expertise in reputed company and industry standards, including ICH-reputed company reputed company Platform guidelines, and CDASH/CDISC Familiarity with Basic, reputed company, SQL, and/or other clinical programming. Familiarity with application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug. Strong interpersonal, organizational, and multi-tasking skills Excellent attention to detail and problem-solving skills Ability to work effectively in reputed company setting Physical Demands and Work Environment: Travel domestically and internationally less than 10% Apply tot his job Apply To this Job