SSO Study Start-up Cluster Head

Job Description Summary

#LI-Hybrid
Location: Singapore
We are seeking a highly motivated and experienced professional to join our Global Drug Development team as the SSO Study Start-Up Cluster Head. This is a hands-on, single contributor role responsible for driving the strategic and operational excellence of study start-up activities across the cluster. The role plays a critical part in ensuring timely and compliant trial initiation, working closely with cross-functional teams and regulatory bodies.
Be part of a global leader in clinical research and innovation. At Novartis, you will contribute to transforming patient lives through science and technology. This role offers the opportunity to shape the future of clinical trial operations and make a tangible impact on global health outcomes.

 

Job Description

Key Responsibilities:

• Define and continuously optimize the cluster study start-up (SSU) strategy in alignment with portfolio and country heads.
• Ensure timely execution of start-up activities from country allocation to Green Light (site initiation readiness).
• Collaborate with global and local stakeholders including IRBs/IECs and Health Authorities to meet regulatory requirements.
• Oversee the accuracy and quality of Trial Master File (TMF) documentation and ensure inspection readiness.
• Implement innovative, efficient processes aligned with Novartis strategy and compliance standards.
• Promote a culture of ethical integrity and adherence to GCP/ICH and local regulations.
• Serve as the escalation point for SSU-related issues and ensure resolution in a timely manner.
• Support resource planning and productivity tracking for SSU activities.
• Interface with global SSU teams to align on timelines, feedback, and issue resolution.
• Contribute to the continuous improvement of operational excellence within the cluster.

Essential Requirements:

• University degree in a scientific or health discipline.

• Minimum 6- 8 years of experience in clinical operations and planning.

• Strong expertise in trial set-up, execution, and monitoring.

• In-depth knowledge of international clinical development standards (GCP/ICH) and regulatory frameworks (FDA/EMA).

• Proven ability to work effectively in a global/country matrix environment.

• Strong interpersonal, negotiation, and conflict resolution skills.

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.

 

Skills Desired

Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management