Clinical Data Manager

The Clinical Data Manager drives the data collection strategy for 3rd party vendor generated test results, championing consistency across programs and alignment with analysis and reporting/exploratory research needs of the trial. Understands a wide variety of external data types and testing methodologies, especially biomarker testing for oncology trials. Serves as the subject matter expert for the setup of external vendors at the trial level. Ensure study set up in Metadata Rave and other EDC systems support data collection requirements for the trial and are aligned with external vendor capabilities. Liaise with 3rd party vendors and central labs. Investigate and resolve issues with external data transfers. Contributes to the standardization of data type specifications to ensure external data transfers to meet EDC requirements, ensures alignment of data transfer with CDASH and SDTM requirements, and with the trial analysis and reporting needs. Manages and provides oversight to the CRO
Creation and maintenance of the data transfer specifications requirements, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Oversight of the standard data formats transferred to the vendor to ensure data expectations for clinical trials. Ensures external data study set up and processes promotes collaboration, alignment and consistency across trials, CROs and vendors. Contributes to the development and application of systems and optimal approaches to support the collection of external data. Effectively collaborates with DM Start-up Leads to define and implement an industry leading electronic data capture capability for external data. Provides oversight of external vendors and reviews work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of the company. Identifies and resolves external data issues which
may negatively impact trial deliverables. Liaises with internal stakeholders (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure collaboration to meet company requirements and timelines. Follows procedural documents and participates in the review and maintenance of procedural documents to ensure alignment with industry standards. Actively participates in and/or leads continuous improvement activities and task forces, as appropriate.

The Data Manager level requires a minimum of 3-5 experience as an external data manager in the pharmaceutical or CRO industry across all trial phases, preferably within the oncology therapeutic area. Project Management skills; excellent organizational skills. In depth knowledge of clinical trials and the drug development process. In depth understanding of a wide variety of external data types and testing methodologies, hands-on experience with clinical data management within the oncology therapeutic area. Knowledge of medical terminology, preferably within oncology. Knowledge of science or a scientific background is preferred. Strong understanding of GCPs, SOPs, regulatory requirements, and Good Data Management Practices. Solid knowledge of CDISC (CDASH, SDTM); understanding of data collection requirements in oncology trials preferred. Understanding of data visualization software for data review and trial oversight (e.g., J-Review, Spotfire, Qlik Sense, etc.).