About the Role
Our client, a pioneering pharmaceutical research organization, is actively recruiting for an experienced Clinical Trial Manager to oversee the execution of complex clinical trials. This fully remote position is integral to ensuring our client's studies are conducted efficiently, ethically, and in compliance with all regulatory standards across various global sites. You will be responsible for the day-to-day management of clinical trials, from planning and initiation through to data analysis and close-out. This role requires exceptional organizational skills, a deep understanding of clinical trial operations, and the ability to lead and motivate cross-functional teams. The fully remote nature of this role allows for flexible work arrangements throughout South Africa , leveraging advanced virtual collaboration technologies. We are committed to advancing medical science and are seeking a leader to drive our clinical trial success.
Key Responsibilities
- Develop comprehensive clinical trial plans, including timelines, budgets, and resource allocation.
- Manage all aspects of clinical trial conduct, ensuring adherence to protocols, SOPs, and regulatory guidelines (GCP, ICH).
- Oversee the selection, training, and performance of clinical trial sites and vendors.
- Monitor trial progress, identify risks and issues, and implement mitigation strategies.
- Ensure the quality and integrity of clinical data through effective monitoring and data management oversight.
- Manage study budgets and track expenses, ensuring projects remain within financial scope.
- Collaborate effectively with internal teams (e.g., regulatory affairs, statistics, medical affairs) and external partners.
- Prepare and present trial status reports to senior management and stakeholders.
- Ensure timely completion of clinical trial activities and final study reporting.
- Contribute to the continuous improvement of clinical trial processes and best practices.
Requirements
- Bachelor's degree in a life science, nursing, or related field; Master's degree or equivalent experience preferred.
- Minimum of 7 years of experience in clinical research, with at least 4 years in a clinical trial management role.
- Proven experience managing multi-center, international clinical trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory submission requirements.
- Strong project management skills, including budget management and risk assessment.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency with clinical trial management systems (CTMS), EDC systems, and other relevant software.
- Ability to work independently and manage multiple complex projects in a remote environment.
- Problem-solving abilities and a proactive approach to challenges.
Benefits
- Our client offers a competitive salary, substantial performance bonuses, comprehensive medical and dental coverage, a robust retirement plan, and generous paid time off.
- We provide extensive opportunities for professional development, including certifications, advanced training, and conference participation.
- This fully remote role offers exceptional work-life balance and the flexibility to work from anywhere within South Africa , backed by comprehensive IT support and collaborative tools.
- Join our team and play a pivotal role in bringing life-changing therapies to patients.