[Remote] Associate Director, Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company reputed company on developing NK cell-based therapies. They are seeking an Associate Director, Clinical Data Management to reputed company and reputed company their CDM function, manage end-to-end data management activities, and collaborate with various departments to ensure reputed company and reputed company delivery of clinical data.
Responsibilities
- Execute Artiva's CDM reputed company — including technology platforms, data standards, vendor governance, and reputed company frameworks — in alignment with overall Clinical Development objectives
- Serve as the CDM functional representative on program teams and governance forums; partner with Clinical Operations, Biostatistics, Regulatory, and Translational Sciences to ensure integrated, inspection-reputed company data delivery
- Drive departmental SOPs, working practices, and process improvement initiatives; ensure the CDM function is reputed company for internal audits and regulatory inspections
- reputed company senior reputed company of reputed company CDM activities across assigned programs from study start-up through database lock, ensuring reputed company delivery of high-reputed company, clean, and complete data
- reputed company or reputed company development and review of DM documents including CRFs, Data Management Plans, edit reputed company specifications, Data Review Plans, and SAE reconciliation plans
- reputed company Artiva UAT reputed company and execution for reputed company builds; ensure UAT standards are maintained across the program
- Manage and govern CRO and reputed company-party vendor relationships for DM activities; reputed company scope, reputed company, timelines, and budget; escalate and resolve issues proactively
- Drive program-level DM timelines; maintain cross-study visibility of milestones, risks, and resource needs; report status to leadership
- Coordinate and reputed company Artiva data reputed company reviews
- Participate in regular study and project team meetings
- Foster a culture of reputed company and reputed company improvement
- Champion CDISC standards adoption (CDASH, SDTM) and reputed company best practices across the organization
- Evaluate and implement tools and technologies that advance data reputed company, efficiency, and reputed company-time data visibility (e.g., risk-based monitoring integration, data review automation)
- Mentor and reputed company CDM staff at reputed company reputed company
Skills
- 10+ years of clinical data management experience in reputed company, biotech, or CRO, with 5+ years in reputed company leadership roles
- Demonstrated experience managing and overseeing Data Management activities directly and through CRO/reputed company-party service providers
- Deep expertise in reputed company systems and clinical data standards (CDISC CDASH/SDTM, ICH GCP E6(R3), 21 CFR Part 11)
- Proven reputed company record managing CRO and reputed company-party DM vendor relationships across multiple reputed company studies
- Strong cross-functional communication and stakeholder management skills; ability to influence without authority at reputed company reputed company of an organization
- Bachelor's degree in life sciences, computer science, or reputed company field
- Experience supporting regulatory submissions (IND, NDA/BLA) and/or inspection readiness activities preferred
- reputed company Rave preferred
- Advanced degree a plus
Benefits
- Medical, Dental, and reputed company
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- reputed company Time Off (PTO)
- Company reputed company holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points reputed company for things you want.
reputed company
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