ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so thatcustomers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience,ERT balances knowledge of what works with a vision for whats next, so we can adapt without compromisingstandards.
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Does Data speak to you? Are you captivated with the many insights thatData can bring to business decisions? If so, consider joiningus as aData Managerand be responsible for ensuring the highest quality data is obtained, processed and reported toour Clinical Trial/Study Sponsors! In the DM role, you will also help define the methods and tools ERT uses to provide these services. OurData Manager is the primary contact for all data-related study issues for both internal and external teams, sostrong client-facingskills will be important to your success. Powered by the companys EXPERT technology platform, ERTs solutions enhance trial oversight, enable siteoptimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuringpatient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies.Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more thanthree million patients to date. By identifying trial risks before they become problems, ERT enables customersto bring clinical treatments to patients quickly and with confidence.
In this role you will: Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited toData collection, Data cleaning, Data delivery, Data reconciliation, Database lock and Data Management activity timelines Define the Data Management Plan (DMP), in collaboration with studySponsors to define study requirements and Queryguidelines Work with internal teams on study setup requirements such as demographic collection and visit schedule requirements. Maintain good communications with relatedteams Lead the development, review, and finalization of data transfer requirements Serve as primary point of contact for query escalation and resolution MaintainData Management Files and prepare study database for archiving for Sponsors and sites Lead status meetings with Sponsor/CRO and internal teams and otherwise communicate project status clearly with Sponsors and Project Management Contribute to continuous process improvement including workflow efficiencies and associated workflow documentation Lead in CAPA issues related to study-specific data management activities Process at least one routine data run per assigned study per quarter and perform all sample, complete and final data sends Assist in the preparation of monthly reporting by providing metrics as required The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Our ideal candidate will offer BS/BA Degree (in the Life Sciences, Business or related field preferred) Minimum of 2 years Data Management or related experience preferably in a clinical research position. Strong client-facing skills/experience are critical to success in this role. Formal project management experience strongly preferred. Strong knowledge of CDISC standards needed. Previous SAS or SQL exposure or experience strongly preferred CCDM certification very helpful/preferred Strong organizational, interpersonal, time-management, and problem-solving skills Ability to manage multiple priorities Strong attention to detail Proficient in Microsoft Office applications Ability to communicate effectively in English We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Associated topics: data administrator, data center, data engineer, data integration, data manager, data scientist, erp, hbase, mongo database, sql
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.