Clinical Operations Manager

Placements24; Bloemfontein; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Retirement savings plan

Paid time off and holidays

Relocation assistance

Professional growth and leadership开发

Job summary

Placements24 is seeking a Clinical Operations Manager in Bloemfontein. The role oversees multiple trials, ensuring ICH-GCP compliance, regulatory adherence, and efficient budgets. You will lead a skilled team, manage CROs and sites, and drive operational excellence across development programs.

Ideal candidates have 7+ years in clinical operations, strong leadership, and experience with CTMS/EDC. The position offers a hybrid work model and career growth opportunities.

Qualifications

• Bachelor's degree in a life science, nursing or related healthcare field; advanced degree preferred.
• Minimum of 7 years of experience in clinical operations within the pharmaceutical/biotech industry.
• Proven experience managing multiple trials from initiation to closure.
• Strong knowledge of ICH-GCP, FDA regulations and global regulatory requirements.
• Excellent leadership, project management, and communication skills.
• Proficiency with CTMS and EDC systems.

Responsibilities

• Plan, manage, and execute clinical trials to timelines, budgets, and quality standards.
• Oversee investigator/site selection and qualification.
• Manage CROs, vendors, and external partners.
• Ensure compliance with ICH-GCP and regulatory requirements.
• Develop and manage trial budgets, forecasts and resources.
• Lead, mentor, and develop the clinical operations team.
• Monitor sites for data integrity and patient safety.
• Present updates to project teams and senior management.
• Contribute to study protocol development and documentation.
• Ensure timely close-out, data reconciliation and archiving.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Budget management

Regulatory compliance

Education

Bachelor's degree in life science or related field

Advanced degree preferred

Tools

CTMS

EDC systems

Job description

About the Role

Our client is a rapidly expanding pharmaceutical company focused on delivering innovative therapeutic solutions. We are seeking a highly capable and experienced Clinical Operations Manager to oversee our clinical trial activities. This role is based in Bloemfontein, Free State, ZA, and offers a flexible hybrid work arrangement, balancing in-office collaboration with remote work flexibility. As the Clinical Operations Manager, you will be responsible for the planning, execution, and oversight of multiple clinical trials, ensuring they are conducted in accordance with GCP, regulatory requirements, and company SOPs. You will manage clinical trial budgets, timelines, and resources, and lead a team of clinical research professionals. The ideal candidate will possess strong leadership skills, a deep understanding of clinical trial management, and a proven ability to navigate complex operational challenges. You will play a critical role in ensuring the quality and efficiency of our clinical development programs, contributing directly to the successful delivery of new medicines. This position requires a proactive individual who can effectively manage cross-functional teams and build strong relationships with investigative sites and vendors. Your expertise will be crucial in driving operational excellence and achieving key milestones in our drug development pipeline.

Key Responsibilities

• Plan, manage, and execute clinical trials according to established timelines, budgets, and quality standards.
• Oversee the selection and qualification of clinical investigators and sites.
• Manage CROs, vendors, and other external partners involved in clinical trials.
• Ensure compliance with ICH-GCP guidelines and all applicable regulatory requirements.
• Develop and manage clinical trial budgets, forecasts, and resource allocation.
• Lead, mentor, and develop the clinical operations team.
• Oversee the monitoring of clinical trial sites and ensure data integrity and patient safety.
• Prepare and present clinical operations updates to project teams and senior management.
• Contribute to the development and review of clinical study protocols and other study documents.
• Ensure timely close-out of clinical trials, including data reconciliation and archiving.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare field; advanced degree preferred.
• Minimum of 7 years of experience in clinical operations within the pharmaceutical or biotechnology industry.
• Proven experience managing multiple clinical trials simultaneously, from initiation to closure.
• Strong knowledge of ICH-GCP, FDA regulations, and other relevant global regulatory requirements.
• Demonstrated leadership and team management skills.
• Excellent project management, organizational, and problem-solving abilities.
• Strong financial acumen and experience managing clinical trial budgets.
• Excellent communication, negotiation, and interpersonal skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to thrive in a hybrid work environment.

Benefits

• Competitive base salary and annual performance bonus.
• Comprehensive health, dental, and vision insurance.
• Generous retirement savings plan.
• Ample paid time off and company holidays.
• Opportunities for professional growth and leadership development.
• Relocation assistance available for qualified candidates.
• Supportive and collaborative work culture.
• Flexible hybrid work model.