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Operations Manager - Clinical SAS Programming

Operations Manager - Clinical SAS Programming

ApicalGo ConsultancyMumbai
14 hours ago
Job description

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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