Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, is seeking a hands-on Senior Clinical Data Manager to support multiple ongoing clinical studies. This role involves performing in-house data management, collaborating closely with Clinical Operations and CRO partners to ensure high-quality and timely clinical data throughout the trial lifecycle.
Responsibilities
- Serve as the sponsor-side Clinical Data Manager for multiple clinical studies
- Act as the primary point of contact for CRO Data Management teams, ensuring deliverables meet quality and timeline expectations
- Perform hands-on clinical data management activities including:
- Ongoing data review and cleaning
- Query management and resolution
- Database/User Acceptance Testing (UAT)
- Database design review and study startup activities
- Collaborate closely with Clinical Operations to proactively identify and resolve data issues
- Monitor study data quality and communicate risks, trends, and issues to internal stakeholders
- Perform database lock activities and ensure data readiness throughout the study lifecycle
- Assist with clinical data visualizations and reporting as needed
- Potentially support in-house SAS-based data review activities as the organization's internal data infrastructure continues to expand
- Partner with cross-functional teams to ensure efficient execution across all data management activities
Skills
- 8+ years of Clinical Data Management experience within biotech or pharma (preferable to have a mix of both small biotech and larger pharmaceutical organizations)
- Ophthalmology clinical trial experience
- Strong hands-on experience managing clinical data from study startup through database lock
- Experience serving as the primary liaison between sponsor teams and CRO Data Management
- Recent hands-on experience performing: User Acceptance Testing (UAT), Query management, Data cleaning and review, Database build review and design, Database lock activities
- Ability to work independently with minimal oversight in a small, fast-paced biotech environment
- Excellent communication skills and strong collaboration with Clinical Operations teams
- Experience with SAS data review tools or SAS Server environments
- Experience working with multiple EDC platforms and CRO-managed databases
- Technical Skills must also include: Electronic Data Capture (EDC) systems (Medidata Rave, Veeva EDC, or equivalent); Database Design & UAT; Query Management; Clinical Data Review & Cleaning; Database Lock; Clinical Data Visualization; SAS (preferred)
- Familiarity with clinical data visualizations and reporting if preferred
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