Clinical Data Manager

Role: Clinical Data Manager overseeing data management activities for multiple clinical programs in a small biotech setting. Responsibilities: manage end-to-end data activities including CRO/vendor oversight, review study documents, support system validation, ensure timely data cleaning and reconciliation, coordinate external data transfers, support medical coding, and contribute to process improvements. Qualifications: BS/MS in life sciences or related field; 8+ years in clinical data management within biotech, pharmaceutical, or CRO environments; experience with oncology and immune-related trials; strong knowledge of EDC systems (e.g., Medidata Rave), GCP, ICH guidelines, and clinical trial data standards (CDISC, SDTM). HighValue: oncology/immune diseases, early-phase trials, complex biomarker/genomic data, external data types (biomarkers, PK/PD, imaging), small biotech environment, vendor management. WorkSetup: Boston-based.