Project Manager, Clinical Trials

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

Benefits offered by this job

Health benefits

Retirement plan

Professional development opportunities

Job summary

Placements24 is seeking an experienced Project Manager to lead pivotal clinical trials in the Paarl region. The role requires strong knowledge of pharmaceutical research, regulatory compliance, and end-to-end project lifecycle management within a healthcare context.

The successful candidate will guide planning, execution, and oversight of trial activities, ensuring adherence to protocols, timelines, budgets, and patient safety, while managing cross-functional teams of investigators, CRAs, and

Qualifications

• 5+ years of experience in clinical trial management within pharma/biotech.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience leading multiple projects with cross-functional teams.

Responsibilities

• Plan and oversee clinical trial activities from start-up to close-out.
• Manage timelines, budgets, and resources to meet milestones.
• Ensure compliance with GCP, FDA/EMA guidelines.
• Coordinate investigators, CRAs, data managers, and study staff.
• Develop study documentation including protocols and CRFs.

Skills

Clinical trial management

Regulatory compliance

Leadership

Cross-functional collaboration

Problem-solving

Education

Bachelor's in Life Sciences

PMP certification (strong asset)

Tools

CTMS

EDC systems

Job description

About the Role

Our client is seeking a meticulous and experienced Project Manager to lead critical clinical trials in the Paarl area. This role demands a deep understanding of pharmaceutical research, regulatory compliance, and project lifecycle management within a healthcare context. You will be responsible for the successful planning, execution, and oversight of clinical trial activities, ensuring adherence to protocols, timelines, and budget constraints. The ideal candidate will possess exceptional organizational skills, strong leadership abilities, and a proven track record in managing complex scientific projects. This position offers a vital role in advancing medical research and developing new therapies.

Key Responsibilities

• Oversee the planning and execution of clinical trials from study start-up to database lock and close-out.
• Manage study timelines, budgets, and resources effectively to ensure project milestones are met.
• Ensure compliance with Good Clinical Practice (GCP), FDA, EMA, and other relevant regulatory guidelines.
• Coordinate activities with investigators, clinical research associates (CRAs), data managers, and other study personnel.
• Develop and maintain project documentation, including protocols, case report forms (CRFs), and study reports.
• Identify and mitigate risks associated with clinical trial execution, ensuring patient safety and data integrity.

Requirements

• Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial phases, regulatory requirements, and ICH-GCP guidelines.
• Proven experience in managing multiple projects simultaneously and working with cross-functional teams.
• Excellent leadership, communication, and problem-solving skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Bachelor's degree in a life science, nursing, or related field; advanced degree or PMP is a strong asset.

Benefits

• A competitive salary and comprehensive benefits package, including health, dental, and retirement plans.
• Opportunity to manage significant clinical research projects in Paarl.
• Contribute to groundbreaking medical advancements and patient care.
• Professional development opportunities and training in clinical research best practices.
• A supportive and collaborative research environment.