Clinical Trial Specialists at Rwanda Food And Drugs Authority (FDA)
Rwanda Food And Drugs Authority (FDA) |
Type: Job
Published: 2024-07-27 | Deadline: 2024-08-05
Job responsibilities
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To contribute to the development and implementation of Rwanda FDA policies and procedures for regulation and inspections of clinical trials and other regulatory services as needed;
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To screen and carry out the review of application for conducting clinical trials;
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To prepare progress reports on clinical trial applications;
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To monitor, update and maintain the register of clinical trials;
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To participate in the development and review of regulations, guidelines, training manuals, SOPs, IEC materials and performance standards;
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To review and make recommendations to approve/or reject clinical trials applications (protocols) on medical products;
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To assure the quality of clinical trials to be compliant with pertinent laws and regulations;
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To participate in the development of regulatory documents and tools (review guidelines, review report templates, and SOPs) to improve the review and approval process of clinical trials applications,
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To update the cumulative list of clinical trial applications,
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To develop and maintain good relations with customers in matters of clinical trial,
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To participate in GCP inspections for authorized clinical trial sites in the country,
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To review, analyze and provide technical advice on reports from clinical trials,
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To participate in planning and budgeting the clinical trial activities within the Pharmacovigilance and safety monitoring division,
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To respond to the customer complaints in mater related to clinical trial,
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To perform tracking of timelines for review and approval of clinical trial applications,
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To maintain good relations with customers and stakeholders in matters of clinical trials,
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To ensure proper record keeping of clinical trial applications and reports,
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To maintain working knowledge in clinical trial activities oversight through regulations, guidelines, published articles, writings, and related courses,
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To perform activities related to quality management Systems in the division
Qualifications
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Bachelor's Degree in Pharmacy
3 Years of relevant experience
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Master's Degree in Pharmacy
1 Years of relevant experience
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Bachelor's Degree in Biotechnology
3 Years of relevant experience
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Master's Degree in Biotechnology
1 Years of relevant experience
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Bachelor's Degree in Veterinary Medicine
3 Years of relevant experience
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Bachelor's Degree in Medicine
3 Years of relevant experience
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Master's Degree in Medicine
1 Years of relevant experience
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Bachelor's Degree in Clinical Research
3 Years of relevant experience
Required competencies and key technical skills
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Resource management skills
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Analytical skills
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Problem solving skills
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Decision making skills
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Time management skills
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Risk management skills
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Performance management skills
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Results oriented
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Digital literacy skills
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Fluency in Kinyarwanda, English and/or French. Knowledge of all is an added advantage.
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Knowledge of data analysis