Job Description Title: Clinical Data Manager Location: Woodcliff Lake, NJ Duration: 1 year (Extendable contract) Responsibilities Independently performs all data management functions to ensure timely and quality database lock for studies Phase I-III. Perform data management activities for EDC studies conducted in‑house as well as oversee activities of off‑shore CRO handling outsourced projects (protocol review, CRF development, database set‑up activities, data validation process; medical coding, SAE reconciliation, etc…). Requirements Minimum 3‑5 years’ experience in Clinical Data Management within pharma or CRO environment. Bachelor degree or above in scientific or related field required. Commensurate experience in Data Management may be considered. Hands‑on experience conducting all DM activities and possess strong project management and excellent interpersonal skills to independently manage a global project. Must have experience with EDC, Inform preferred but open to other EDC such as RAVE, etc. Experience in some Oncology preferred. Knowledge of I‑Review/J‑Review a plus. Significant hands on experience when performing DM tasks, particularly with regards to general data review, discrepancy management and external data reconciliation. Oncology experience is a must, especially when dealing with Tumor reconciliation (RECIST 1.1, IrRECIST mRECIST etc…). Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Computer proficiency and knowledge of medical terminology. Strong oral and written communication skills. Additional Information This job is with one of my Financial Client. #J-18808-Ljbffr
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