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)