• Overseeing and managing local clinical trials;
• Contributing to the development and management of budgets, timelines and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks;
• Compiling and driving documentation for the project, ensuring the accuracy and quality of regulatory data;
• Ensuring clinical trials are effectively executed and completed within budget, timelines and meeting enrolment commitments as well as routine updating clinical systems;
• Pro-active trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties;
• Ensuring management of trials are done in compliance with ICH, GCP, global standards, local laws and regulations;
• Co-monitoring with a CRA.
Required skills, experience:
• Excellent site monitoring and management skills;
• Experience in managing local trials;
• Minimum four years of relevant clinical research experience in pharmaceutical or CRO industries;
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
• Ability to train and supervise junior staff;
• Ability to work under minimal supervision.
• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Fluency in local language and English language.