Job Description

• Clinical Data Manager, providing oversight to ensure complete, accurate and high-quality data collection for outsourced and in-house trials.
• Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial
• Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging).
• Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors.
• Write or contribute to preparation of CDM documents.
• Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output.
• In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings.
• Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions.

• Bachelor's Degree in life sciences or related discipline, minimum 5+ years of experience in clinical data management or relevant work experience.
• CRO or CDM vendor management experience in oncology.
• Early phase adaptive trial management experience preferred.
• Experience with CDASH terminology and/or MedDRA and Who Drug medical coding.
• Experience with SAS programming techniques is a plus.
• Experience with RaveX and/or Veeva EDC is a plus.
• Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines.
• Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization.

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