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Part-Time (10-15 hours/week), 6-Month Contract with potential to extendThe contract Clinical Data Manager will contribute to database development, data quality oversight, and vendor coordination to ensure accurate and compliant data. The ideal candidate will bring strong hands-on experience and a collaborative mindset, working closely with cross-functional teams to drive successful trial execution.
What You Will Contribute
- Review protocols for appropriate data capture in clinical database.
- Support database build activities including review of eCRFs, edit check specifications, and data listings.
- Support eCRF design, review, and validation of clinical databases.
- Provide oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
- Conduct oversight of data management vendors via ongoing review of quality and performance metrics.
- Generate, resolve, and track data queries to ensure the integrity of the clinical data.
- Facilitate and participate in?data?cleaning activities.
- Generate and/or review/approve study documents (e.g. DMP, eCCGs)
- Responsible for maintaining internal data management timelines and metrics.
- Maintain study DM related documents/files for inspection readiness.
- Proactively identify potential data management issues/risks and communicate them within the study team for further action.
What We Seek
- Minimum BA/BS in scientific or health-related field.
- 10+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry
- Experience managing study-level data management activities and working with external vendors.
- Proficient with Medidata RAVE; experience working on Medidata Suite products preferred.
- Familiarity with various data visualization, analytics, and reporting tools is a plus (e.g. Power BI, Spotfire).
- Working knowledge of the clinical drug development process, FDA/MAA regulatory requirements, ICH/GCP guidelines, CDISC standards, and industry standard practices regarding DM
- Excellent communication skills, strong organizational skills, and ability to work independently and effectively prioritize tasks in a fast-paced setting.
- Detail-oriented with effective problem-solving and troubleshooting skills
- Process oriented with the ability to understand complex data and information
- Significant experience using Microsoft Office Suite including Project, Excel, PowerPoint required; Experience with SharePoint or similar work management software/systems highly preferred