Operations Manager
1 week 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 :
- 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, ).
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