Clinical Data Associate

divh2Clinical Data Manager/h2pPrimarily responsible for the business, operational, and compliance aspects of drug discovery, development, and marketed products. Clinical data managers work collaboratively with internal and external colleagues and vendors to support Gileads business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes./ppProject Involvement/pulliMay lead a study or group of related small studies./liliDemonstrates the ability to lead a study (ies)/project(s) with minimal supervision./liliServes as a point of contact for study management team./liliEffectively interact with cross-functional team/li/ulpKey Differentiating Contributions/pulliAssists in implementing routine activities involving CDM interaction with other study management team members./liliReviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner./liliIdentifies, tracks, and resolves routine queries and issues./liliThe point of contact for Clinical Research regarding data management issues./liliDemonstrates ability to identify problems early and communicate escalation issues appropriately./li/ulpJob Responsibilities/pulliWorks collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting./liliDemonstrates a general understanding of each assigned protocol, critical tasks and milestones./liliEnsure completeness, accuracy and consistency of routine clinical data and data structure./liliAssists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer and reporting./liliMay lead in the preparation of CRF/eCRF design./liliReviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries./liliUtilizes routine reports to track study progress and ensures timeliness and quality expectations are met./liliExcellent verbal and written communication skills and interpersonal skills are required./liliThe ability to problem solves and have people/project leadership skills./liliKnowledge of FDA/EMA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems./liliDemonstrates understanding of project timelines and metrics to ensure databases are delivered to set timelines./li/ulpTypical Education Experience/pulli3 years of experience and a BS degree./li/ul/div