Contract Clinical Data Mgr

Contract Clinical Data Manager (East Coast) Remote Position

No 3rd parties or corp to corp

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Must have current pharma/biotech experience

* Our client, a top-level pharmaceutical company is seeking a Clinical Data Manager to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual. Works with involved parties to assure that DMM is prepared according to company SOPs and in compliance with data standards. Coordinates, leads, and performs clinical data management activities for assigned studies in accordance with SOPs and policies and practices.

Responsibilities

Serves as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study. Coordinates, leads, and performs clinical data management activities for assigned studies in accordance with SOPs and policies and practices including, not limited to: Monitors data clean-up process performed by CROs from study start-up through data archiving. Provides data for analysis. Coordinates activities including medical coding; data validation checks and database snapshot. Prepares and distributes project status reports to project team and management. Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with SOPs. Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF. Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Requirements: Implementing clinical data platform. Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. Possess excellent communication and project management skills. Bachelor’s degree in Mathematics, Science or a related field. 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry. Previous oncology or ophthalmology experience is a plus. Experience in early phase. Please contact Darren Gutowski at [email protected]