Sr. Clinical Data Manager

Minimum of 10 Years of Experience. This is a 100% Remote role.
Position Summary:
Responsible for coordination and oversight of data management activities in support of the clinical trials/programs

Duties and Responsibilities:
Clinical sub-team member works closely with the Clinical Trial Manager and is responsible for oversight 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/Google Cloud Platform guidelines and current regulatory requirements.
Participates in database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines, and related operations manuals.
Participates in database build and UAT.
Develops data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check 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 projects.
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 projects.
Provides input and participates in the development of clinical study documents, including protocol and monitoring plans.
Supports CTM in the coordination of receipt of all 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 healthcare degree
Experience minimum 5+ years in a pharmaceutical/biotech, CRO setting, global/international experience a plus
Expertise in EDC and industry standards, including ICH-Google Cloud Platform guidelines, and CDASH/CDISC
Familiarity with Basic, SAS, 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 a team setting

Physical Demands and Work Environment:
Travel domestically and internationally less than 10%