Clinical Trials Projects & Operations Manager

Abantu Staffing Solutions (Pty) Ltd; Oos-Kaap; On-site; ZAR 800,000 - 1,200,000; Full time

Job summary

Abantu Staffing Solutions (Pty) Ltd is seeking a senior Program & Operations Manager to lead multiple clinical trial programs across all phases. You will oversee timelines, budgets, and milestones, ensuring regulatory compliance and cross-functional alignment.

You will mentor Heads of Departments, drive performance, and contribute to strategic planning in a fast-paced, matrixed environment. Strong knowledge of ICH-GCP and global regulations is essential.

Qualifications

• Experience in clinical trials with 3+ years in a senior project or operations management role.
• Strong knowledge of ICH-GCP, FDA, EMA and other global regulatory requirements.
• Proven leadership in mentoring and driving performance across cross-functional teams.
• Excellent communication and stakeholder management in fast-paced, matrixed environments.

Responsibilities

• Lead planning, execution, and delivery of multiple clinical trial programs across all phases.
• Oversee timelines, budgets, milestones, and regulatory compliance.
• Partner with cross-functional teams to ensure seamless program execution.
• Mentor heads of departments and drive organizational capability.

Education

Tertiary Qualification in Project Management/ Healthcare or related field

Job description

Responsibilities:

Program Management

• Lead the planning, execution, and delivery of multiple clinical trial programs across all phases.
• Oversee project timelines, budgets, and milestones, ensuring adherence to contractual and regulatory requirements.
• Partner with cross-functional teams (Clinical Operations, Data Management, Biostatistics, Regulatory, etc.) to ensure seamless program execution.
• Identify risks, issues, and dependencies; implement mitigation strategies proactively.

Operations Management

• Develop and optimize operational processes to improve efficiency, quality, and compliance across clinical programs.
• Manage resource allocation and workload balancing across projects and teams.
• Establish and monitor key performance indicators (KPIs) to track program and operational performance.
• Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs.

Leadership & Stakeholder Management

• Act as the key point of contact for sponsors, senior leadership, and cross-functional stakeholders.
• Mentor, guide and drive performance of Heads of Departments and operations staff to build organizational capability.
• Contribute to strategic planning, business development initiatives, and continuous improvement efforts.
• Communicate program progress, risks, and operational updates to executive leadership.

Requirements:

• Tertiary Qualification in Project Management/ Healthcare or related field
• Experience in clinical trials, with at least 3+ years in a senior project or operations management role.
• Strong knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements will be an added advantage
• Demonstrated experience in managing complex, multi-phase programs.
• Proven leadership skills with experience in mentoring, managing and driving performance of cross-functional teams
• Strong financial and resource management skills.
• Excellent communication, negotiation, and stakeholder management abilities.
• Ability to thrive in a fast-paced, matrixed environment.