About the Role
Our client, a reputable pharmaceutical organization, is seeking an experienced and highly organized Clinical Trial Manager to oversee the planning, execution, and successful completion of clinical trials. This hybrid role offers a blend of remote management capabilities and essential on-site collaboration within the Randburg, Gauteng, ZA area. You will be responsible for managing all aspects of clinical trials, from protocol development through to final reporting, ensuring compliance with regulatory standards, timelines, and budgets. The ideal candidate possesses strong project management skills, a deep understanding of clinical trial operations, and excellent leadership abilities. This is a key position requiring a proactive approach to problem-solving and a commitment to driving efficient and ethical research practices that advance pharmaceutical development.
Key Responsibilities
- Develop comprehensive clinical trial plans, including timelines, budgets, and resource allocation.
- Oversee the selection and management of clinical investigative sites and vendors.
- Ensure trial conduct complies with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
- Manage clinical trial budgets, tracking expenditures and ensuring adherence to financial targets.
- Lead and motivate cross-functional clinical trial teams, fostering collaboration and efficient communication.
- Develop and maintain study documentation, including protocols, investigator brochures, and case report forms (CRFs).
- Monitor trial progress, identify risks and issues, and implement corrective action plans.Liaise with regulatory authorities, ethics committees, and other stakeholders.
- Ensure the timely collection, management, and analysis of clinical trial data.
- Prepare clinical study reports and contribute to regulatory submissions.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- A Master's degree or equivalent experience is highly desirable.
- Minimum of 5 years of experience in clinical trial management within the pharmaceutical or CRO industry.
- Proven experience in managing multiple clinical trials simultaneously.
- In-depth knowledge of clinical trial processes, regulatory requirements (GCP, ICH), and drug development lifecycle.
- Strong project management skills, including budget management, risk assessment, and timeline control.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software.
- Ability to work independently and manage remote teams effectively.
- Detail-oriented with strong organizational and problem-solving abilities.
- Experience with Phase I-IV clinical trials across various therapeutic areas.
Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan.
- Generous paid time off and company holidays.
- Professional development and training opportunities.
- Travel opportunities for site visits and conferences.
- Company-provided laptop and mobile phone.
- A stimulating work environment with opportunities for career growth.
- Supportive management and a collaborative team atmosphere.
- Impactful role in bringing new therapies to market.