QSSR-COM-CLINICAL OPERATIONS MANAGER

by | Feb 11, 2025

  • Full Time
  • Kigali

Website AKAGERA MEDICINES

General Responsibility:
Our mission is to utilize the cutting-edge science and bring innovative therapies and vaccines for neglected infectious diseases; a future where patients have access to safe and effective treatment options, especially in the low- and middle-income countries. We are a small group of energetic, problem-solvers focused on innovation, and looking to bring transformative medicines or treating infectious diseases. If you want to make an impact with your career, while making a difference in other people’s lives, here is your chance.
 
The Clinical Operations Manager will support in executing the study level activities for ongoing and future clinical trials. He/she is a member of a growing clinical team dedicated to achieving and exceeding business objectives through efficient execution, high quality and timely deliverables of all associated aspects of the trial, in compliance with regulatory requirements and Good Clinical Practice guidelines.
 
Duties & Responsibilities:
  1. Responsible for trial management to ensure all aspects of trials are executed as planned
  2. Manage and oversee all activities of contract research organization (CRO)
  3. Participate in review of contracts (CROs, sites, etc.)
  4. Manage clinical site preparation and validation activities
  5. Establish and maintain the Trial Master File (TMF) including essential and non-essential documents. Ensure current copies of lab certificates, regulatory approvals, research personnel credentials, etc., are updated in a timely manner and are in compliance.
  6. Establish relationship with CRO and/or study site personnel to keep track of patient enrollment and treatment schedules. Ensure patient follow-ups for clinical results are received in timely manner.
  7. Ensure the conduct of the study is in compliance with the currently approved protocol/amendment(s), with current GCP guidelines and with applicable regulatory requirements.
  8. Maintain investigational product accountability and traceability – Ensure product shipped, necessary to meet study requirements and usage for each enrolling patient per clinical site.
  9. Manage and support the clinical trial support team
  10. Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project
    timelines.
  11. Verifications of clinical activities and review of invoices according to the budget
  12. Reporting status of the trial to senior management. 
  13. Perform other duties as assigned to ensure successful management and completion of clinical trial.

Requirements

Education:
​
Bachelor’s degree in a clinical, scientific or health-related discipline or equivalent experience.
Key Attributes (experience, skills and technical knowledge):

• Minimum 3 years’ experience in managing operational activities of clinical trials is required.

• Previous experience running global trials is an asset.

• Must have a good working knowledge of medical terminology and an excellent knowledge of applicable U.S. and international investigational regulations and guidelines.

• Excellent oral and written communication, organizational and planning skills.

• Detail-oriented, a self-starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small rapidly growing company environment.

• Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects

• Direct experience in managing a clinical trial support team, CRO is an asset.

To apply for this job please visit qsourcing.zohorecruit.com.