Operations Manager
2 weeks ago
Job Summary : We are seeking a detail-oriented and proactive Operations Manager to oversee the day-to-day operations of our Clinical SAS Programming team. This role is critical in ensuring the timely delivery of programming outputs, optimizing team workflows, and supporting cross-functional collaboration across clinical development, biostatistics, and data management.Key Responsibilities : Operational Oversight : - Manage timelines, resource allocation, and deliverables for clinical programming projects.- Track progress against milestones and proactively address risks or delays.- Ensure compliance with regulatory standards (CDISC, FDA, ICH-GCP).Team Coordination : - Facilitate communication between programmers, statisticians, and data managers.- Support onboarding, training, and performance tracking of programming staff.- Promote a culture of accountability, collaboration, and continuous improvement.Process & Quality Management : - Implement and maintain SOPs, workflows, and documentation standards.- Drive automation and efficiency improvements in programming operations.- Monitor quality metrics and ensure audit readiness.Stakeholder Engagement : - Serve as the point of contact for operational updates to leadership and project teams.- Coordinate with global teams to align on priorities and resource needs.- Support strategic planning and capacity forecasting.Qualifications : Education & Experience : - Bachelors or Masters degree in Life Sciences, Computer Science, or related field.- 7+ years of experience in clinical SAS programming, with 2+ years in a leadership or operations role.Skills & Competencies : - Good understanding of clinical trial processes and CDISC standards (SDTM, ADaM).- Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).- Excellent organizational, communication, and problem-solving skills.- Ability to manage multiple priorities in a fast-paced environment.Preferred Qualifications : - PMP or similar project management certification.- Experience working in a CRO or pharmaceutical company.- Familiarity with regulatory submission processes (e.g., eCTD, define.xml). (ref:hirist.tech)
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