Job Description
Responsibilities: - 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.
Requirements: - 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.
Katalyst HealthCares and Life Sciences
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