Clinical Data Manager

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. • 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. This job is with one of my Financial Client. Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at .