Clinical Data Management II Direct Hire MA

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Job ID: 16089 Direct Hire MA

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Clinical Data Manager II

Summary: Ensure quality and timely clinical data delivery from start to close out. Establish appropriate application of data standards and perform quality assurance review of key clinical data management (CDM) deliverables.


• Monitor clinical data quality and progress of trials outsourced to CROs; drive corrective actions as needed

• Leads medical coding and the development of eCRF Completion Guidelines

• Ensure clinical databases are structured in alignment with case report forms and data standards

• Manages timelines and oversees quality standards

•  Performs all the data management tasks in support of Phase I – IV gene therapy clinical studies

• Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings as appropriate

• Facilitates cross-functional data review for assigned studies


• Bachelor’s Degree and 4 or more years CDM and/or clinical trial operations experience

• 2 or more years of experience in managing outsourced work or working for a CRO

• GCP knowledge

• EDC skills, including Medidata Rave and IBM Health

• Strong understanding of clinical trial data

• Ability to review high volumes of data for quality issues; attention to detail

• Organizational, planning and project management skills

• Interpersonal, communication, and negotiation skills

• Ability to operate effectively in a team environment