SSO Study Start-Up Manager

Novartis Pharmaceuticals Corporation; Riyadh; On-site; SAR 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a dedicated SSO Study Start-Up Manager to oversee study planning and SSU activities. This role is crucial for ensuring compliance with regulatory requirements and leading a collaborative team to achieve project milestones. You will engage with various stakeholders, manage local vendor performance, and contribute to the success of clinical trials. Join a supportive work environment that values diversity and offers ample development opportunities in the vibrant city of Riyadh, Saudi Arabia.

Benefits

Development opportunities

Innovative medicines

Supportive work environment

Diversity and inclusion initiatives

Qualifications

• Minimum 5 years’ experience in clinical operations or monitoring.
• Ability to lead in a matrix environment without direct reports.

Responsibilities

• Support country SSU strategy in collaboration with various teams.
• Ensure timely start-up activities and manage local compliance documentation.
• Lead local SSU team activities to achieve timelines and quality standards.

Skills

Clinical monitoring

Research

Protocol development

Decision-making

Regulatory compliance

Interpersonal skills

Negotiation skills

Conflict resolution

Effective communication

Education

Degree in scientific or health discipline

Advanced degree preferred

Job description

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# SSO Study Start-Up Manager
REQ-10050814
May 01, 2025
Saudi Arabia

Summary

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. The role involves leading all SSU activities in collaboration with the SSO Feasibility Manager, SSO Site Partnership Manager, and the global study team. In satellite countries, acts as primary backup and deputy to the country manager.

About the Role

Major accountabilities:

• Support country SSU strategy in collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio, and SSO Cluster Head Portfolio.
• Collaborate with various teams to meet SSU timelines and deliverables according to country commitments.
• Ensure timely start-up activities from country allocation to Green Light milestone.
• Coordinate with IRBs/IECs, Health Authorities, and prepare submission packages.
• Manage local documentation, compliance, and communication with stakeholders.
• Oversee local vendor performance and site readiness for drug release.
• Lead local SSU team activities to achieve timelines and quality standards.
• Participate in global study team meetings and develop site initiation and patient enrollment plans.

Key performance indicators:

• Performance against study commitments, timelines, and milestones.
• Adherence to legislation, ICH/GCP, and regulatory requirements.
• Quality and timeliness of documentation and data submissions.

Minimum Requirements:

Work Experience:

• Degree in scientific or health discipline; advanced degree and clinical trial experience preferred.
• Minimum 5 years’ experience in clinical operations or monitoring.
• Ability to lead in a matrix environment without direct reports.
• Understanding of drug development processes, standards, and regulations.

Skills:

• Clinical monitoring, research, protocol development, decision-making, regulatory compliance.
• Strong interpersonal, negotiation, and conflict resolution skills.
• Effective communication in a global matrix environment.

Languages:

• Fluent in English; local language as needed.

Why Novartis:

Join our Novartis Network to benefit from development opportunities, innovative medicines, and a supportive work environment in Saudi Arabia, Riyadh. We are committed to diversity and inclusion in our teams.