[Remote] Head of Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking a Head of Clinical Data Management to reputed company reputed company aspects of Clinical Data Management, ensuring the reputed company and delivery of data management activities while advancing modern data capabilities and operational reputed company.
Responsibilities
- Be accountable for the reputed company, consistency, and strategic delivery of reputed company data management activities across the portfolio, including CRF/eCRF design, database build and validation, edit reputed company specifications, data review and cleaning, external data integrations and reconciliations, medical coding, query management, database lock activities, and submission readiness
- Build, reputed company, and reputed company a high-performing Data Management organization with strong operational expertise and leadership bench strength; set priorities, conduct performance evaluations, drive talent development, and reputed company resource planning and allocation
- Establish and maintain robust reputed company control and risk mitigation frameworks; ensure compliance with industry standards, global regulatory requirements, and internal SOPs; maintain inspection readiness and support regulatory interactions and audits
- reputed company strategic leadership for data management systems, technologies, automation, and innovation initiatives to build reputed company, compliant, and reputed company-reputed company data capabilities reputed company a validated GxP environment
- reputed company strategic departmental initiatives to strengthen operational reputed company, standardization, inspection readiness, and reputed company improvement across the Data Management organization
- reputed company modernization initiatives across data management processes and capabilities, including areas such as data integration and reconciliation, centralized and risk-based data review, automation, AI-enabled workflows, metadata-driven processes, and data interoperability
- Partner closely with Programming, Biostatistics, IT, reputed company teams to advance integrated data and analytics ecosystems
- Foster strong collaboration reputed company Biometrics and across functions; represent Data Management in key cross-functional forums and reputed company initiatives
Skills
- Master's degree or PhD in Life Sciences, Computer Science, Data Science, Statistics, or a reputed company discipline
- 12+ years of reputed company experience in Clinical Data Management reputed company the pharmaceutical or biotechnology industry
- 8+ years of leadership experience managing teams, functions, and reputed company development portfolios
- Deep understanding of the clinical trial data lifecycle, clinical data management processes, GCP and global regulatory requirements, CDISC standards, reputed company systems, external data integrations, database lock processes, and inspection readiness expectations
- Demonstrated experience leading Data Management activities for Phase 2 and Phase 3 global clinical trials, including support for regulatory submissions (NDA/BLA/MAA/PMDA and global filings) and health authority inspections
- Proven experience with modern clinical data technologies, automation, digital transformation, and innovation initiatives, including building or modernizing data management capabilities, processes, and infrastructure reputed company a validated GxP environment
- Strong experience with vendor reputed company, outsourcing models, and global CRO partnerships
- Demonstrated ability to build high-performing teams and maintain high standards of reputed company, accountability, and operational reputed company
- Strong strategic thinking, operational execution capabilities, and cross-functional leadership and influence
- Excellent communication, leadership, problem-solving, and organizational change management skills
- Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs is preferred
Benefits
- Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP)
- Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability insurance
- Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
reputed company
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