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.