SSO Study Start-Up Manager

Novartis Farmacéutica; Riyadh; On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a dedicated Study Start-Up Manager to oversee study planning and activation deliverables. This role involves ensuring compliance with regulatory requirements and leading SSU activities in collaboration with global teams. The ideal candidate will have a strong background in clinical operations, excellent project management skills, and the ability to thrive in a matrix environment. Join a passionate community committed to transforming lives through innovative science and contribute to groundbreaking projects that make a real difference.

Qualifications

• 5+ years’ experience in clinical operations or monitoring clinical trials.
• Strong understanding of clinical drug development and trial setup.
• Ability to lead in a matrix environment without direct reports.

Responsibilities

• Ensure SSU timelines and deliverables are met with global study team.
• Coordinate with local IRBs/IECs and Health Authorities for approvals.
• Manage local SSU team activities to meet timelines and quality standards.

Skills

Clinical Monitoring

Research

Trial Protocol expertise

Decision-making

Drug Development

Regulatory Compliance

Interpersonal skills

Negotiation

Conflict Resolution

Effective Communication

Education

Degree in a scientific or health discipline

Advanced degree preferred

Job description

The SSO Study Start-Up Manager is responsible for study planning, SSU activities, and activation deliverables of assigned projects, ensuring compliance with Novartis processes, GCP/ICH, and regulatory requirements within a standalone country, OPC, or satellite country. They lead all SSU activities in collaboration with the SSO Feasibility Manager, SSO Site Partnership Manager, and the global study team. In satellite countries, they act as the primary backup and deputy of the country manager.

About the Role

Major accountabilities:

1. Support country SSU strategy in collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio, and SSO Cluster Head Portfolio.
2. Ensure SSU timelines and deliverables are met in coordination with the global study team and SSO Portfolio Team Leads.
3. Manage timely start-up activities from country allocation until Green Light approval.
4. Coordinate with local IRBs/IECs and Health Authorities for submissions and approvals.
5. Prepare and finalize local submission packages for IRB/IEC, CTA Hub, and Health Authorities, including amendments and study reports.
6. Respond promptly to deficiency letters and manage reportable events and notifications.
7. Maintain accurate and inspection-ready country TMF documents.
8. Ensure adherence to financial, legal, ICH/GCP, IRB/IEC, Health Authority, and SOP requirements.
9. Implement innovative processes aligned with Novartis strategy.
10. Support study feasibility and site selection in collaboration with relevant teams.
11. Oversee local vendor selection and performance, addressing quality and compliance issues.
12. Ensure site readiness for Green Light and drug release, reviewing and signing off on site documentation.
13. Manage local SSU team activities to meet timelines and quality standards, proposing corrective actions when necessary.
14. Lead local SSU team meetings and participate in global study team meetings.
15. Develop country site initiation and patient enrollment plans with SSU CRA, CPM, and SSU Lead.

Key performance indicators:

1. Performance against study commitments, including patient enrollment and milestone achievement.
2. Adherence to legislation, ICH/GCP, IRB/IEC, and Health Authority requirements.
3. Timely and high-quality submission of clinical trial documentation/data.

Qualifications:

• Degree in a scientific or health discipline; advanced degree and clinical trial experience preferred.
• Minimum 5 years’ experience in clinical operations or monitoring clinical trials.
• Ability to lead in a matrix environment without direct reports.
• Strong understanding of clinical drug development, trial setup, execution, and monitoring.
• Excellent project management, problem-solving, and mediation skills.
• Knowledge of international drug development standards, regulations, and Novartis standards.

Skills:

• Clinical Monitoring, Research, and Trial Protocol expertise.
• Decision-making, Drug Development, and Regulatory Compliance skills.
• Strong interpersonal, negotiation, and conflict resolution abilities.
• Effective communication in a global matrix environment.

Languages:

• Fluent in written and spoken English; proficiency in local language as needed.

Why Novartis: Join us to help transform lives through innovative science. Be part of a passionate community committed to breakthroughs and a brighter future. More info: https://www.novartis.com/about/strategy/people-and-culture

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