Clinical Data Mgr

Clinical Data Manager – Southern, NJ (Hybrid or Remote)
Responsibilities

The Clinical Data Manager drives the data collection strategy for 3rd party vendor‑generated test results, championing consistency across programs and alignment with analysis, reporting and exploratory research needs of the trial. Understanding a wide variety of external data types and testing methodologies, especially biomarker testing for oncology trials, the manager serves as the subject‑matter expert for the setup of external vendors at the trial level.

Ensuring that study set‑up in Metadata Rave and other electronic data capture systems supports the trial’s data collection requirements and aligns with vendor capabilities, the manager liaises with 3rd‑party vendors and central labs, investigates and resolves issues with external data transfers, and contributes to the standardization of data type specifications to meet EDC, CDASH and SDTM requirements. The manager oversees the creation and maintenance of data transfer specifications, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting.

They also ensure that standard data formats transferred to vendors meet expectations for clinical trials, promote collaboration, alignment and consistency across trials, CROs and vendors, develop and apply systems and optimal approaches to support external data collection, and collaborate with DM Start‑up Leads to define and implement an industry‑leading electronic data capture capability for external data. Oversight of external vendors and review of work delivered by external partners such as laboratories, eCOA providers and technology providers is performed, and external data issues that may negatively impact trial deliverables are identified and resolved.

Liaising with internal stakeholders—including Biomarker Operations, Data Management, Data Analytics, Medical, Statistics and others—and external partners ensures collaboration to meet company requirements and timelines. The manager follows procedural documents, participates in the review and maintenance of procedural documents to ensure alignment with industry standards, and actively participates in or leads continuous improvement activities and task forces as appropriate.

• Minimum of 3–5 years of 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 and 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, with hands‑on experience in clinical data management within the oncology therapeutic area.
• Knowledge of medical terminology, preferably within oncology, and a scientific background or knowledge of science.
• Strong understanding of GCPs, SOPs, regulatory requirements and Good Data Management Practices.
• Solid knowledge of CDISC standards (CDASH, SDTM) and understanding of data collection requirements in oncology trials.
• Understanding of data visualization software for data review and trial oversight (e.g., J‑Review, Spotfire, Qlik Sense).