Clinical Data Manager

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com. 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.