SSO Study Start-Up Team Lead

Novartis (Singapore) Pte Ltd; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company in Singapore seeks a professional to lead and manage the study start-up process. The ideal candidate has over 5 years of clinical operations experience and proven leadership skills. Responsibilities include ensuring compliance with regulatory standards and overseeing documentation processes. Join a diverse team committed to innovation and excellence in clinical trials.

Qualifications

• Minimum 5 years of experience in clinical operations and planning.
• Proven leadership experience in study start-up.
• Strong knowledge of international regulatory standards.

Responsibilities

• Lead the end-to-end study start-up process.
• Ensure high-quality TMF documentation throughout the study lifecycle.
• Drive innovation and improve operational processes.

Skills

Leadership

Interpersonal skills

Regulatory knowledge

Conflict resolution

Communication skills

Education

Bachelor’s degree in a scientific or health discipline

Job description

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.