Senior Clinical Operations Manager

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work model

Medical benefits

Retirement planning

Job summary

Placements24 seeks a Senior Clinical Operations Manager to lead and oversee clinical trials in the Mpumalanga region. You will manage site selection, patient recruitment, data collection, and study monitoring, working with CRAs and site staff to drive efficiency and compliance.

The role requires strong leadership, budgeting, and regulatory knowledge, with opportunities to influence trial design and execution across Phases II and III in a hybrid work setting.

Qualifications

• 8+ years of progressive experience in clinical operations, preferably in pharma/CROs.
• Proven track record managing multiple trials including Phases II/III.
• Strong knowledge of ICH-GCP, regulatory requirements, and SOPs.

Responsibilities

• Lead planning, execution, and monitoring of trials from initiation to close-out.
• Manage team of CRAs and clinical operations staff, providing guidance.
• Oversee site selection, initiation, monitoring, and close-out activities.
• Ensure compliance with ICH-GCP and regulatory requirements across sites.
• Develop and manage study budgets, resources, and vendor oversight.
• Collaborate with data management, regulatory, and external partners.

Skills

Leadership

Project management

Communication

Team management

Clinical operations

Education

Bachelor's degree in life science/healthcare

Advanced degree

Job description

About the Role

Our client is seeking a highly experienced Senior Clinical Operations Manager to lead and oversee the execution of clinical trials in the Mpumalanga region. This role is critical for ensuring that clinical trials are conducted efficiently, ethically, and in compliance with all regulatory standards. You will manage clinical trial site selection, patient recruitment, data collection, and study monitoring, working closely with clinical research associates (CRAs) and site staff. This senior position offers the opportunity to drive excellence in clinical operations and contribute to bringing life-changing therapies to patients.

Key Responsibilities

• Lead the planning, execution, and monitoring of clinical trials from initiation to close-out, ensuring adherence to timelines and budgets.
• Manage a team of Clinical Research Associates (CRAs) and other clinical operations personnel, providing guidance and oversight.
• Oversee site selection, qualification, initiation, monitoring, and close-out activities.
• Ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs across all study sites.
• Develop and manage study budgets, resource allocation, and vendor oversight.
• Collaborate with internal departments (e.g., data management, regulatory affairs) and external partners to ensure successful trial conduct.

Requirements

• Bachelor's degree in a life science, nursing, or healthcare-related field.
• Advanced degree is a plus.
• Minimum of 8 years of progressive experience in clinical operations within the pharmaceutical or CRO industry.
• Proven experience in managing multiple clinical trials simultaneously, including Phase II and III studies.
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
• Excellent leadership, project management, and communication skills.
• Experience working within the South African healthcare system and understanding local regulatory nuances.

Benefits

• Competitive salary and comprehensive benefits package, including medical and retirement planning.
• Hybrid work model offering flexibility and balance in Nelspruit .
• Significant opportunities for professional development and career advancement.
• Exposure to diverse therapeutic areas and innovative trial designs.
• A collaborative environment focused on delivering high-quality clinical research.