SSO Study Start-Up Team Lead

4 weeks ago

Singapore Novartis (Singapore) Pte Ltd Full time

Key Responsibilities:

  • Lead and manage the end-to-end study start-up process from country allocation to site Green Light (ready-to-initiate).
  • Support the development and execution of the country/OPC study start-up strategy in alignment with global and local priorities.
  • Collaborate with internal stakeholders including Portfolio Heads, Global Study Teams, and Health Authorities to ensure timelines and deliverables are met.
  • Ensure high-quality and inspection-ready Trial Master File (TMF) documentation throughout the study lifecycle.
  • Drive innovation and continuous improvement in operational processes to enhance performance and productivity.
  • Oversee hiring, training, development, and retention of Study Start-Up associates about 12 team members
  • Serve as the escalation point for study start-up issues and ensure timely resolution.
  • Ensure compliance with ICH/GCP, IRB/IEC, Health Authority regulations, and Novartis SOPs.
  • Partner with SSU CRAs and global SSU managers to align on portfolio deliverables and essential document collection.
  • Monitor and report on productivity targets and performance metrics.

Essential Requirements:

  • Bachelor's degree in a scientific or health discipline
  • Minimum 5 years of experience in clinical operations and planning, with a strong focus on study start-up.
  • Proven leadership experience, with or without direct line management responsibilities.
  • In-depth understanding of clinical drug development, especially trial set-up and execution.
  • Strong knowledge of international regulatory standards (ICH/GCP, FDA, EMA) and local Health Authority regulations.
  • Experience working in a global or country matrix environment.
  • Excellent interpersonal, negotiation, and conflict resolution skills.
  • Strong communication skills in a cross-functional, multicultural environment.
  • Ability to lead teams and drive results in a dynamic, high stakes setting

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams

representative of the patients and communities we serve.

#J-18808-Ljbffr

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