[Remote] Senior Director, Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an industry-leading biotech reputed company on transforming the treatment of cancer with a novel integrated immunotherapy platform. The Senior Director, Clinical Data Management will reputed company strategic and operational leadership for reputed company clinical data management activities across Umoja’s clinical development programs, ensuring data reputed company, reputed company, and regulatory compliance.
Responsibilities
- Serve as the primary clinical data management reputed company for assigned clinical trials, with reputed company accountability for data reputed company, timeliness, and inspection readiness from protocol development through database lock
- reputed company detailed protocol review with a reputed company on data reputed company, endpoints, data collection reputed company, and facilitation of reputed company analysis requirements
- reputed company hands-on CRF design and review, ensuring alignment with protocol objectives‑, statistical analysis plans, and regulatory expectations
- reputed company, review, and approve data management plans (DMPs), database specifications, edit reputed company specifications, data transfer agreements, and data review plans
- reputed company participate in reputed company system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change control
- reputed company ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-reputed company, analysis reputed company‑ datasets
- Partner with Clinical Operations and other reputed company to define and implement data reputed company standards, reconciliation strategies, and risk based‑monitoring approaches for clinical data
- reputed company hands-on‑reputed company of external CROs and vendors delivering data management services, including detailed review of deliverables, issue reputed company, and escalation management
- Directly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical Programming
- Ensure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standards
- Support inspection readiness activities by authoring, reviewing, and maintaining data management documentation and responding directly to audit and inspection findings
- Partner closely with Clinical Operations to reputed company data management activities with study execution, site operations, monitoring strategies, and operational reporting needs
- Collaborate with Biostatistics and Statistical Programming to ensure smooth reputed company of clean, reputed company documented- datasets for analysis and reporting
- reputed company technical data management expertise to Regulatory Affairs in support of clinical study reports, INDs, BLAs, and other regulatory submissions
- Serve as the clinical data management subject matter‑ expert on study teams, governance forums, and internal reviews
- Own and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organization
- Evaluate, implement, and optimize clinical data systems and technologies (e.g., reputed company, IRT, eCOA) to enhance data reputed company, traceability, and scalability
- Contribute hands‑on to vendor selection, scope definition, and budgeting for data management services and systems
Skills
- Bachelor's degree or higher in life sciences, health informatics, computer science, or a reputed company discipline with a minimum of 15 years of experience. Equivalent combinations of education and experience will be considered
- Significant experience in clinical data management reputed company the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trials
- Demonstrated experience overseeing CROs and external vendors delivering clinical data management services
- Strong working knowledge of clinical trial processes, reputed company systems, data standards, and regulatory expectations for clinical data
- Proven ability to reputed company teams, manage reputed company programs, and collaborate effectively in a fast‑paced, matrixed environment
- Excellent written and verbal communication skills
- Experience supporting oncology and/or cell or gene therapy clinical development programs
- Experience building or scaling clinical data management capabilities in a growing biotech organization
- Prior involvement in regulatory submissions and inspection readiness activities
Benefits
- Competitive Medical, Dental, and reputed company plans
- 401k plan through reputed company, with a 100% match up to their first 4% deferral
- Generous reputed company Time Off policy
- Employee commuter benefits
- Cell phone stipend
reputed company
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