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.

Responsibilities:

• 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

Requirements:

• 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