Africa Clinical Research Network (ACRN) is an African-led clinical research organization building the next generation of trial capacity across the continent. We work with existing hospitals, research units, and investigators to enable high-quality clinical research—from investigator-initiated studies to late-phase and registration trials—while strengthening local systems, skills, and infrastructure.

ACRN operates as a pan-African site management and research delivery platform, combining strong clinical operations, regulatory expertise, data and digital systems, and quality management. Our model is practical and embedded: we focus on making trials work in real settings, reducing friction for sites, sponsors, and regulators, and delivering reliable, audit-ready data.

We partner closely with governments, regulators, academic institutions, and industry to expand Africa’s role in global clinical research, while ensuring that studies generate local value—through workforce development, institutional strengthening, and improved patient care.

At ACRN, you’ll work on meaningful, complex projects with global impact, alongside a multidisciplinary team that values rigor, accountability, and innovation. We are building something durable, ambitious, and distinctly African—and we are looking for people who want to help shape it.

About the role

We are seeking a highly motivated Clinical Operations Manager to join our Clinical Operations department. As a vital member of our team, you will play a key role in overseeing and optimizing clinical operational activities to ensure excellence in execution. This full-time, fixed-term position offers an exciting opportunity to collaborate with cross-functional teams, ensuring the highest standards of efficiency and compliance in clinical trials.

What you'll do

1. Portfolio-Level Operational Oversight

• Provide operational oversight for a defined portfolio of clinical trials across multiple countries.
• Ensure studies are executed in accordance with ICH-GCP, regulatory requirements, protocols, sponsor expectations, and ACRN SOPs.
• Monitor portfolio performance, delivery timelines, and operational health indicators.

2. Functional Leadership and Oversight

• Provide functional oversight and guidance to Clinical Trial Managers, CRAs, and site-level coordination teams (without direct line management).
• Review study plans, monitoring strategies, and site performance metrics.
• Act as a senior escalation point for study-level delivery, quality, and compliance issues.

3. Study Start-Up, Execution, and Close-Out Governance

• Oversee study start-up readiness, including regulatory activation, site preparedness, and operational planning.
• Ensure consistent execution standards across active studies.
• Support orderly and compliant study close-out activities.

4. Quality, Risk, and Inspection Readiness

• Drive a continuous state of inspection readiness across assigned studies.
• Oversee identification, documentation, and resolution of protocol deviations, monitoring findings, and CAPAs.
• Partner with Quality Assurance to embed risk-based quality management across the portfolio.

5. Monitoring and CRA Coordination

• Ensure monitoring activities are executed to standard and in line with risk-based monitoring plans.
• Review monitoring outputs, site findings, and follow-up actions.
• Support CRA performance consistency and escalation of persistent site issues.

6. Cross-Functional Coordination

• Work closely with Regulatory Affairs, Data Management, Pharmacovigilance, Medical Affairs, IT, and Laboratory teams.
• Ensure operational plans align with regulatory, data, safety, and quality requirements.
• Support integrated problem-solving across functions.

7. Sponsor and Stakeholder Engagement

• Serve as a senior operational contact for sponsors on assigned studies or programs.
• Support sponsor meetings, issue resolution, and expectations management.
• Escalate sponsor-level risks or concerns to the Director of Clinical Operations as appropriate.

8. Performance Reporting and Continuous Improvement

• Review and interpret operational metrics, risks, and trends across the portfolio.
• Provide structured updates and recommendations to senior leadership.
• Identify opportunities to improve operational efficiency, consistency, and scalability.

Qualifications

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Public Health, Pharmacy, or a related field.

Preferred Qualifications

• Advanced degree or professional certification in clinical research or project management.

Required Experience

• 8–12 years’ experience in clinical research operations.
• Demonstrated experience overseeing multiple clinical trials in regulated environments.

Preferred Experience

• Experience in CRO/SMO or multi-country clinical research organizations.
• Experience supporting audits, inspections, and complex sponsor programs.

Core Competencies

• Strong operational leadership and portfolio coordination capability.
• Advanced understanding of ICH-GCP and global regulatory requirements.
• High attention to detail, risk management, and quality governance.
• Ability to influence and lead through matrix structures.
• Clear, confident communication with senior stakeholders.

Performance Expectations

• Clinical trial portfolios are delivered predictably and compliantly.
• Quality and operational risks are identified early and mitigated effectively.
• Monitoring, deviations, and CAPAs are managed consistently across studies.
• Sponsors and leadership demonstrate confidence in operational oversight.

Application closes on 13 March 2026

PIea752dec7000-37437-40219002

American Friends of Mutala jobs

Human Resources Clerk

Clinical Operations Manager

Director Clinical Operations

Never Miss a New Opportunity