Clinical Research Manager

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Hybrid work model

Job summary

Placements24 in Mbombela (Nelspruit) seeks a Clinical Research Manager to lead planning, execution, and close-out of clinical trials, ensuring data integrity, patient safety, and regulatory compliance. This hybrid role requires on-site oversight at the Nelspruit facility and remote coordination of study activities, budgets, timelines, and resources, with strong leadership and GCP expertise.

Applicants should have 6–8 years in clinical research with management experience and proficiency in

Qualifications

• Bachelor’s degree in life science or related field.
• 6–8 years in clinical research with at least 3 years in management.
• Thorough knowledge of GCP and ICH guidelines.
• Proven ability to manage multiple trials simultaneously.
• Strong project management, communication, and leadership skills.
• Experience with CTMS and EDC systems.
• Hybrid work model with onsite Nelspruit oversight.

Responsibilities

• Plan, manage, and oversee clinical trials from initiation to closure.
• Ensure activities comply with GCP, regulatory requirements, and study protocols.
• Mentor CRAs and other study personnel.
• Develop and manage study budgets and timelines.
• Oversee site selection, initiation, monitoring, and close-out.
• Ensure accurate collection, review, and reporting of data.
• Liaise with investigators, sites, regulatory authorities, and internal teams.
• Identify and mitigate risks in trial conduct.
• Contribute to study protocols and informed consent forms.
• Prepare regulatory submissions and contribute to study reports.

Skills

Project management

Leadership

Regulatory compliance

GCP/ICH knowledge

Communication

Problem solving

Organizational skills

Clinical trial management software

Education

Bachelor's degree in life sciences

Master's degree preferred

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading pharmaceutical research organization with expanding operations in **Nelspruit**, is seeking a highly organized and experienced Clinical Research Manager. This critical role involves overseeing the planning, execution, and completion of clinical trials, ensuring compliance with regulatory standards and company protocols. The ideal candidate will have a strong background in clinical research, exceptional project management skills, and a thorough understanding of Good Clinical Practice (GCP) guidelines. This is a hybrid position, requiring a balance of remote coordination of research activities and team members, alongside essential on-site presence at the **Nelspruit** facility for oversight, site visits, and management meetings. You will be responsible for managing study timelines, budgets, resources, and ensuring the highest standards of data integrity and patient safety. This is an opportunity to contribute significantly to the development of life-saving therapies within a reputable organization.

Key Responsibilities

• Plan, manage, and oversee clinical trials from initiation to closure.
• Ensure all clinical trial activities are conducted in compliance with GCP, regulatory requirements, and study protocols.
• Manage and mentor clinical research associates (CRAs) and other study personnel.
• Develop and manage study budgets and timelines, ensuring efficient resource allocation.
• Oversee site selection, initiation, monitoring, and close‑out activities.
• Ensure accurate and timely collection, review, and reporting of clinical data.
• Liaise with investigators, study sites, regulatory authorities, and internal teams.
• Identify and mitigate risks associated with clinical trial conduct.
• Contribute to the development of study protocols, informed consent forms, and other study‑related documents.
• Prepare regulatory submissions and contribute to study reports.

Requirements

• Bachelor's degree in a life science, nursing, or a related healthcare field; Master's degree preferred.
• Minimum of 6-8 years of experience in clinical research, with at least 3 years in a management or supervisory role.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in managing multiple clinical trials simultaneously.
• Strong project management, organizational, and problem‑solving skills.
• Excellent communication, interpersonal, and leadership abilities.
• Proficiency in clinical trial management software (CTMS) and electronic data capture (EDC) systems.
• Ability to work effectively in a hybrid model, balancing remote coordination with regular on-site requirements in **Nelspruit**.
• Experience in pharmaceutical or biotechnology industry research.
• Must be adaptable and detail‑oriented.

Benefits

• Opportunity to manage impactful clinical trials for a leading pharmaceutical research organization in **Nelspruit**.
• Competitive salary and benefits package, including health insurance and retirement contributions.
• Hybrid work model offering flexibility and essential local engagement.
• Professional development and opportunities for career advancement in clinical research management.
• Be part of a team dedicated to advancing medical science and improving patient outcomes.
• Contribute to the development of innovative new therapies.