Senior Pharmaceutical Clinical Operations Manager

Placements24; Sandton; Hybrid; ZAR 1,000,000 - 1,700,000; Full time

Benefits offered by this job

Private health insurance

Retirement fund

Paid time off

Career development

Job summary

Placements24 is seeking a Senior Pharmaceutical Clinical Operations Manager to oversee clinical trial operations in Sandton, Gauteng. You will lead multi-phase trials, manage study timelines, budgets, and resources, and ensure ethical conduct and regulatory compliance.

The role requires 7+ years in clinical operations, strong leadership, vendor management with CROs, and a track record of delivering trials on time and within budget. Hybrid work in Sandton with travel for site visits and meetings.

Qualifications

• 7+ years of progressive experience in clinical operations management within the pharmaceutical industry.
• Demonstrated experience managing complex clinical trials from inception to completion.
• In-depth knowledge of GCP, ICH guidelines, and regulatory submission processes.

Responsibilities

• Lead and manage the execution of clinical trials across various phases and therapeutic areas.
• Oversee clinical trial site selection, initiation, monitoring, and close-out activities.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and regulatory submission processes.
• Develop and manage clinical trial budgets, timelines, and resource allocation.
• Select, manage, and oversee Contract Research Organizations (CROs) and other vendors.
• Develop and implement clinical operational plans and strategies.
• Ensure accurate and timely data collection, monitoring, and reporting.
• Manage and mentor clinical research associates (CRAs) and other clinical operations staff.
• Liaise with internal departments (e.g., Regulatory Affairs, Data Management, Biostatistics) and external stakeholders.

Skills

Leadership

Budget management

Vendor management

GCP/ICH knowledge

Project management

Team management

Communication

Education

Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or related field

Tools

CTMS

EDC

Job description

About the Role

Our client, a pioneering pharmaceutical organization, is searching for an accomplished Senior Pharmaceutical Clinical Operations Manager to oversee and direct clinical trial operations in Sandton, Gauteng, ZA . This leadership position requires extensive experience in managing all aspects of clinical trials, from study start-up to database lock, ensuring trials are conducted efficiently, ethically, and in compliance with global regulatory standards. The successful candidate will play a vital role in bringing innovative medicines to patients by managing clinical study timelines, budgets, and resources effectively. This is a significant career opportunity within the thriving pharmaceutical sector of Gauteng, ZA .

Key Responsibilities

• Lead and manage the execution of clinical trials across various phases and therapeutic areas.
• Oversee clinical trial site selection, initiation, monitoring, and close-out activities.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and other relevant regulatory requirements.
• Develop and manage clinical trial budgets, timelines, and resource allocation.
• Select, manage, and oversee Contract Research Organizations (CROs) and other vendors.
• Develop and implement clinical operational plans and strategies.
• Ensure accurate and timely data collection, monitoring, and reporting.
• Manage and mentor clinical research associates (CRAs) and other clinical operations staff.
• Liaise with internal departments (e.g., Regulatory Affairs, Data Management, Biostatistics) and external stakeholders.

Requirements

• Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• A minimum of 7 years of progressive experience in clinical operations management within the pharmaceutical industry.
• Demonstrated experience managing complex clinical trials from inception to completion.
• In-depth knowledge of GCP, ICH guidelines, and regulatory submission processes.
• Proven experience in vendor management (CROs) and budget oversight.
• Strong leadership, team management, and motivational skills.
• Excellent project management abilities, with a track record of delivering projects on time and within budget.
• Outstanding communication, negotiation, and interpersonal skills.
• Ability to travel as required for site visits and meetings.

Benefits

• Our client offers a competitive salary, bonus opportunities, and a comprehensive benefits package, including private health insurance, a retirement fund, and generous paid time off.
• They are committed to employee growth, providing ample opportunities for professional development and career advancement.
• This hybrid role offers flexibility, allowing for a balance between on-site strategic planning in Sandton, Gauteng, ZA and remote work efficiency.