SSO Study Start-Up Lead - Africa

Novartis; Midrand; On-site; ZAR 300 000 - 400 000; Full time

Job summary

A leading pharmaceutical company is seeking an SSO Study Start-Up Manager to oversee study planning, SSU activities, and activation deliverables for projects in South Africa. The ideal candidate will have at least 5 years of experience in clinical operations, particularly with trial start-up and management. Responsibilities include ensuring compliance with regulatory standards, leading local SSU activities, and collaborating with cross-functional teams to achieve study milestones. This role requires strong project management skills and effective communication in a matrix environment.

Qualifications

• Minimum 5 years’ experience in clinical operations overseeing clinical trials.
• Capable of leading in a matrix environment without direct reports.
• Thorough understanding of international standards (GCP/ICH).
• Strong project management capabilities to solve complex issues.

Responsibilities

• accountable for timely start-up activities from country allocation until Green Light.
• Coordinates timely response to deficiency letters with stakeholders.
• Ensures adherence to financial standards and ICH/GCP requirements.

Skills

Strong interpersonal skills

Negotiation skills

Effective time management

Regulatory compliance

Education

Degree in scientific or health discipline

Job description

A leading pharmaceutical company is seeking an SSO Study Start-Up Manager to oversee study planning, SSU activities, and activation deliverables for projects in South Africa. The ideal candidate will have at least 5 years of experience in clinical operations, particularly with trial start-up and management. Responsibilities include ensuring compliance with regulatory standards, leading local SSU activities, and collaborating with cross-functional teams to achieve study milestones. This role requires strong project management skills and effective communication in a matrix environment.