SSO Study Start-Up Manager

Novartis; Saudi Arabia; On-site; SAR 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dynamic Study Start-Up Manager to lead clinical operations. This role involves ensuring compliance with regulatory requirements and managing study timelines and deliverables. The ideal candidate will have a strong background in clinical trials and project management, with the ability to navigate complex matrix environments. Join a forward-thinking company where your expertise will contribute to innovative processes and impactful patient outcomes. If you are passionate about drug development and thrive in collaborative settings, this opportunity is perfect for you.

Qualifications

• Minimum 5 years in clinical operations, overseeing or monitoring trials.
• Strong understanding of drug development processes and trial setup.

Responsibilities

• Manage timely start-up activities from country allocation to Green Light.
• Coordinate with local IRBs/IECs and Health Authorities for approvals.
• Lead local SSU team activities and meetings, collaborating with global teams.

Skills

Clinical Monitoring

Project Management

Regulatory Compliance

Interpersonal Skills

Problem Solving

Effective Communication

Education

Degree in a scientific or health discipline

Advanced degree and clinical trial experience

Job description

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 the primary backup and deputy of the country manager.

About the Role
Major accountabilities:

• Supports country SSU strategy in collaboration with the SSO Study Start-Up Team Lead, SSO Country Head, and SSO Cluster Head.
• Ensures SSU timelines and deliverables are met in collaboration with relevant teams.
• Manages timely start-up activities from country allocation to Green Light in assigned projects.
• Coordinates with local IRBs/IECs and Health Authorities for submissions and approvals.
• Prepares and finalizes local submission packages for IRB/IEC, CTA Hub, and Health Authorities, including amendments and reports.
• Responds to deficiency letters and manages reportable events with stakeholders.
• Ensures accuracy and timeliness of country TMF documents for inspection readiness.
• Adheres to financial standards, legislation, ICH/GCP, and SOP requirements.
• Implements innovative processes aligned with Novartis strategy.
• Supports feasibility and site selection processes.
• Oversees local vendor performance and manages quality/compliance issues.
• Prepares sites for Green Light, ensuring documentation is complete and accurate.
• Leads local SSU team activities and meetings, collaborating with global teams.
• Develops site initiation and patient enrollment plans with relevant teams.

Key Performance Indicators
1. Performance against study commitments (patients, timelines, milestones).
2. Delivery of milestones adhering to legislation and standards.
3. Quality and timeliness of documentation/data submission.

Minimum Requirements
Work Experience:

• Degree in a scientific or health discipline; advanced degree and clinical trial experience preferred.
• Minimum 5 years in clinical operations, overseeing or monitoring trials.
• Ability to lead in a matrix environment without direct reports.
• Understanding of drug development processes, especially trial setup, execution, and monitoring.
• Strong project management and problem-solving skills.
• Knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), and local regulations.

Skills:

• Clinical Monitoring, Research, Protocols, Trials.
• Decision Making, Drug Development, Regulatory Compliance.
• Interpersonal, negotiation, and conflict resolution skills.
• Effective communication in global/matrixed environments.

Languages:
Fluent in English; local language proficiency as needed.

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