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Director Data Management
hace 2 semanas
Job Title: Director, Data Management (Life Sciences) Location: Remote - travelling between sites will be required Department: Clinical Operations / Biometrics Reports To: VP, Clinical Development / Head of Data Management Position Summary The Director of Data Management is a senior leadership role responsible for overseeing end‑to‑end clinical data management activities across multiple drug development programs. This role ensures high‑quality, compliant clinical data delivery, drives data strategy, and leads a team of data management professionals. The ideal candidate has extensive experience in life sciences—particularly clinical trials—along with proven line management and cross‑functional leadership capabilities. Key Responsibilities Strategic Leadership & Oversight Develop and lead data management strategy for clinical studies across all phases (I–IV). Establish standards, processes, and best practices to ensure high‑quality, timely, and compliant data. Drive adoption of innovative data technologies, EDC solutions, automation, and advanced analytics. Collaborate closely with Clinical Operations, Biostatistics, Medical, Regulatory, and external vendors to align data strategy with program goals. Operational Excellence Oversee the planning, design, and execution of data management activities, including CRF development, database build, data validation, coding, and database lock. Ensure compliance with GCP, ICH guidelines, regulatory requirements, and internal SOPs. Manage vendor performance (CROs, EDC providers, data analytics vendors) and ensure quality deliverables. Mitigate risks, resolve data issues, and drive continuous process improvement. Team & Line Management Lead, mentor, and develop a team of data managers, including senior staff and managers. Conduct performance reviews, establish goals, and support career development planning. Create a culture of collaboration, accountability, and operational excellence. Ensure adequate staffing, resource planning, and talent development across programs. Cross‑Functional Collaboration Serve as a primary Data Management representative in study team meetings and leadership forums. Communicate data risks, timelines, and quality metrics to senior leadership. Partner with Biostatistics and Clinical Operations to ensure seamless data flow and readiness for analysis. Qualifications Required Bachelor’s degree in Life Sciences, Data Science, Biostatistics, or related field (Master’s preferred). 10+ years of data management experience within the pharmaceutical, biotech, or CRO industry. Demonstrated leadership of clinical data management for global clinical trials. 5+ years of line management experience, including hiring, mentoring, and performance management. Strong knowledge of EDC systems (e.g., Medidata Rave, Oracle Inform, Veeva), CDISC standards, and relevant regulatory requirements. Proven ability to lead multiple clinical programs simultaneously in a fast‑paced environment. Excellent communication, stakeholder management, and problem‑solving skills. Preferred Previous experience as a Data Management Department Lead or Senior Manager in a life sciences organization. Experience with decentralized trials, eCOA, wearable/real‑world data, or advanced data strategies. Knowledge of statistical concepts and familiarity with programming languages (e.g., SAS, SQL) is a plus. Please apply via LinkedIn or send your CV to . #J-18808-Ljbffr
