Job Description

• Support the Lead Data Manager across one or more clinical studies.
• Reviews protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provide expertise and support oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
• Reviews or generates study documents (Data Management Plan, CRF Completion Guidelines, DB build specifications, Edit Check Specifications, Data Transfer Specifications, SAE and/or External Data Reconciliation Plans, Coding Guidelines, Vendor Management Plans, etc.).
• Review CRF metrics reports against project data deliverables.
• Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
• Leads the Data Review plan check, specification and validation updates.
• Facilitates and participates in scheduled and ad hoc data listing review.
• Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.
• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
• Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
• Maintains study DM related documents/files for inspection readiness.
• Conducts the SAE and external vendor data reconciliation.
• Review and may distribute/coordinate data management metrics, listings, and reports.
• Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
• Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
• Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness.

• Minimum BA/BS in scientific or health-related field.
• Minimum of 9-11 years of clinical data management experience in the pharmaceutical, and biotechnology industry or in a CRO.
• At least 1 year experience working at a Sponsor.
• Oncology trial experience required, hematology/oncology preferred.
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice.
• Proficient with Medidata RAVE.
• Experience with working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
• Familiarity with various data visualization, analytics, and reporting tools is a plus
• Excellent communication skills (verbal and writing).
• Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
• Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
• Strong organizational skills and ability to prioritize tasks.
• Proven ability to work independently and in a team setting.

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