Clinical Trial Manager (CTM) - Phase III Studies

Placements24; South Africa; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Placements24 seeks an experienced Clinical Trial Manager to oversee complex Phase III trials from initiation to closure. The role combines site selection, vendor oversight, risk management, and cross-functional leadership, ensuring timelines, budgets, and regulatory compliance are met in a hybrid Paarl-based setting.

The ideal candidate will bring 5+ years in CTM, strong project management, and expertise with CTMS/EDC systems, working effectively with CRAs, data managers and regulatory teams.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Master's degree in a relevant field is preferred.
• Minimum 5 years of progressive CTM experience in pharma/biotech.
• Proven track record managing Phase III trials and regulatory compliance.

Responsibilities

• Oversee planning, execution, and completion of Phase III trials.
• Develop and manage trial budgets and timelines.
• Select, train, and manage investigational sites; oversee CRAs and site staff.
• Oversee vendor relationships (CROs, central labs, IRBs) and risk plans.
• Ensure GCP, ICH guidelines, and regulatory compliance; monitor KPIs and progress.

Skills

Project management

Leadership

Communication

Interpersonal skills

Education

Bachelor's degree in Life Sciences/related field

Master's degree preferred

Tools

CTMS

EDC

Job description

About the Role

Our client is seeking an experienced and dynamic Clinical Trial Manager (CTM) to oversee the execution of complex Phase III clinical trials for their innovative therapeutic pipeline. This role, based in Paarl, Western Cape , requires a skilled leader to manage all aspects of trial conduct, ensuring adherence to timelines, budgets, and regulatory standards. This position offers a hybrid work model, providing flexibility while ensuring essential on-site presence for critical trial activities and team collaboration. As a CTM, you will be responsible for site selection and management, vendor oversight, risk assessment, and ensuring patient safety and data integrity. You will work closely with a multidisciplinary team, including CRAs, data managers, regulatory affairs specialists, and investigators, to achieve trial milestones. The ideal candidate will possess strong project management skills, a deep understanding of clinical trial operations, and a proven ability to lead teams effectively in a challenging research environment.

Key Responsibilities

Oversee the planning, execution, and completion of assigned Phase III clinical trials. Develop and manage clinical trial budgets, ensuring adherence to financial projections. Select, train, and manage investigational sites, ensuring compliance with protocols and regulations. Oversee the activities of Clinical Research Associates (CRAs) and other site staff. Manage relationships with third-party vendors (e.g., CROs, central labs, IRBs). Develop and implement risk management plans to identify and mitigate potential trial issues. Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements. Monitor trial progress, key performance indicators (KPIs), and timelines, implementing corrective actions as needed. Review and approve essential trial documents, including protocols, investigator brochures, and monitoring plans. Liaise with internal departments (e.g., Regulatory Affairs, Drug Safety, Biostatistics) to ensure seamless trial execution. Facilitate internal and external trial-related meetings.

Requirements

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field. Master's degree preferred. Minimum of 5 years of progressive experience in clinical trial management within the pharmaceutical or biotechnology industry. Proven track record of successfully managing Phase III clinical trials from initiation to closure. In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes. Experience with site management, monitoring, and vendor oversight. Strong project management skills, including budget management, timeline planning, and risk assessment. Excellent leadership, communication, and interpersonal skills. Ability to work effectively in a hybrid environment, balancing remote responsibilities with on-site requirements. Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software. Experience in a specific therapeutic area is an advantage.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including excellent medical coverage, retirement savings plan, performance bonuses, and paid time off. The hybrid work model provides flexibility, and the role is based in Paarl, Western Cape . Employees will benefit from opportunities for professional development, advanced training, and career advancement within a growing pharmaceutical organization. You will be part of a dedicated team focused on bringing critical new medicines to patients, working in a stimulating and supportive environment.