3 Job Positions of Clinical Trial Specialist at FDA Under Statute :Deadline: Aug 5, 2024

Job responsibilities

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; To screen and carry out the review of application for conducting clinical trials; To prepare progress reports on clinical trial applications; To monitor, update and maintain the register of clinical trials; To participate in the development and review of regulations, guidelines, training manuals, SOPs, IEC materials and performance standards;

To review and make recommendations to approve/or reject clinical trials applications (protocols) on medical products; To assure the quality of clinical trials to be compliant with pertinent laws and regulations; 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, To update the cumulative list of clinical trial applications, To develop and maintain good relations with customers in matters of clinical trial, To participate in GCP inspections for authorized clinical trial sites in the country, To review, analyze and provide technical advice on reports from clinical trials,

To participate in planning and budgeting the clinical trial activities within the Pharmacovigilance and safety monitoring division, To respond to the customer complaints in mater related to clinical trial, To perform tracking of timelines for review and approval of clinical trial applications, To maintain good relations with customers and stakeholders in matters of clinical trials, To ensure proper record keeping of clinical trial applications and reports, To maintain working knowledge in clinical trial activities oversight through regulations, guidelines, published articles, writings, and related courses, To perform activities related to quality management Systems in the division,

• • 1

    Bachelor’s Degree in Pharmacy

    3 Years of relevant experience

• • 2

    Master’s Degree in Pharmacy

    1 Years of relevant experience

• • 3

    Bachelor’s Degree in Biotechnology

    3 Years of relevant experience

• • 4

    Master’s Degree in Biotechnology

    1 Years of relevant experience

• • 5

    Bachelor’s Degree in Veterinary Medicine

    3 Years of relevant experience

• • 6

    Bachelor’s Degree in Medicine

    3 Years of relevant experience

• • 7

    Master’s Degree in Medicine

    1 Years of relevant experience

• 8

  Bachelor’s Degree in Clinical Research

  3 Years of relevant experience

Required competencies and key technical skills

• • 1
    Resource management skills

• • 2
    Analytical skills

• • 3
    Problem solving skills

• • 4
    Decision making skills

• • 5
    Time management skills

• • 6
    Risk management skills

• • 7
    Performance management skills

• • 8
    Results oriented

• • 9
    Digital literacy skills

• • 10
    Fluency in Kinyarwanda, English and/or French. Knowledge of all is an added advantage.

• 11
  Knowledge of data analysis

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