Summary
Date Posted: Thursday, August 18, 2022 , Base Salary: Not Disclosed

JOB DETAILS:
Clinical Trial Manager

Position Code: CTM -822
Reports to: Head of Programme
Station: Entebbe

Job Purpose:
The position holder is responsible for the coordination of clinical trials in collaboration with the Principal Investigator and other scientists working on the trials. The Trial Manager interacts closely with the statisticians, study coordinators, Project Leads, Data Managers, Programmers, and other trial staff as part of the Trial team. S/he will also be responsible for the day-to-day coordination of their clinical study/ies, working with the other members of the team and the sites to ensure the successful delivery of the study. The main duties of the post include training the site staff on the trial procedures, writing documentation, monitoring the data, and ensuring that all regulatory requirements are met in a timely manner.

Roles & Responsibilities
1. Principal duties;
• Producing trial documentation according to scientific requirements of the protocol and in line with the regulations and MRC/UVRI and LSHTM Uganda Research Unit’s guidelines for data collection and management;
• Promoting the trials to ensure wide participation and good accrual of patients. This will include assisting in the production of newsletters, site visits, attendance of scientific conferences, and meetings, and presenting information about the trials;
• Assist with developing programmes, agendas for regular team meetings, and possibly national and international meetings;
• Support the Project Lead to provide training, information, and advice to Trial Clinicians, Research Nurses, and Pharmacists on all protocol requirements;
• Ensuring all essential documentation is in place at the Unit and trial sites in preparation for regulatory inspections, audits, and trial closure;
• Contribute to the development of Standard Operating Procedures and plans for the study;
• The Trial Manager will also take responsibility for or oversee the Contract Research Organization and other partners responsible for the on-site monitoring of the clinical sites, where necessary, to ensure that sites are following the protocol and Good Clinical Practice (GCP) guidelines; to source monitor important outcomes, Serious Adverse Events, clinical endpoints and referring significant issues to the Principal Investigator (PI) or Trial Physicians;
• Work with the site compliance teams to ensure that the regulatory requirements are met;
• Ensure the timely submission of data and documents from sites to the MRC/UVRI and LSHTM Uganda Research Unit PI and the necessary reports from the trial team to appropriate regulatory, ethical, and funding parties;
• Work with the study coordinators across all sites to prepare the site regulatory packages (including Clinical Trial Agreements, Material Transfer Agreements, Investigator Brochures, etc.);
• Maintaining liaison with the study coordinators from all other sites to review and assist in the preparation of appropriate responses for re-submission if necessary;
• In collaboration with the trial monitors, ensure the study team reviews and approves all documents (could co-opt the monitors to ensure this is done) prior to submission and implementation at all the sites and tracks all documentation across the sites;
• Receive/obtain copies of all Institutional Review Board (IRB) submissions and circulate IRB responses to the study team; circulate Regulatory Authority submissions for review and update the team members;
• Compile and maintain the central Trial Master File as per GCP;
• Coordinate the purchasing, delivery, and coordination of the trial drug supplies and ensure that site accountability processes are in place and being followed if required;
• Preparation and presentation of written and oral reports to the Trial Management Group, Trial Steering Committee, or other groups and/or at scientific meetings;
• Assist in MRC/UVRI and LSHTM Uganda Research Unit audit processes; and,
• Any other comparable tasks as required by the PI.

Person Specification
• University/Bachelor’s degree (or higher) in a health-related field;
• Should possess recent experience in the conduct of clinical trials involving investigational medicinal products;
• Proven working experience in implementing GCLP/GCP;
• Proven experience in study trial document development including protocols, case report forms (CRFs), manuscripts, study reports, and Standard Operating Procedures
• (SOPs);
• Experience working in clinical research;
• Experience working within the clinical trials environment;
• Experience in study trial document development including protocols, CRFs, study
• reports, Study Operations Manual, and Standard Operating Procedures;
• Experience supervising/mentoring staff;
• Previous experience or knowledge of coordinating multi-centred International clinical trials in HIV;
• Previous experience in performing clinical trial on-site monitoring within national and International settings;
• Experience in coordinating, organizing, and presenting at meetings;
• Should possess demonstrable understanding of clinical trials methodology and stages in the testing of new products and other interventions, and excellent knowledge of current regulatory requirements governing clinical trials including a practical understanding of GCP;
• Understanding of the regulations and governance environment for clinical research in Uganda/internationally;
• Good computer skills with experience in Microsoft Office will willingness to learn new packages;
• Familiarity with database software and tools used for sample management;
• Understanding of the regulations and governance environment for International Clinical trials;
• Knowledge of project management processes and tools;
• Project coordination;
• Quality management;
• Academic/scientific writing;
• Excellent oral and written communications skills with experience in communicating effectively with people across multiple disciplines;
• Excellent organizational; skills- able to manage multiple projects, work to deadlines and prioritize work effectively using a pragmatic and diplomatic approach to problem solving;
• Good team member but able to work independently as required; and,
• Willingness to travel within Uganda and/or Internationally.


Job Experience: No Requirements

Work Hours: 8

Level of Education: Bachelor Degree

Job application procedure

Follow the link below to fill out a form and submit your application documentation: https://redcap.link/Clinical_Trial_Manager 
Filling the form more than once will lead to automatic disqualification. High level of integrity while filling the form is required and will be considered during shortlisting.
Combine all your application documentation i.e. cover letter, CV & certified copies of academic documents into one PDF document. Deadline for application is 26th August 2022, 5:00 pm. Only shortlisted candidates will be contacted for interview. This position is open to Ugandan nationals only. Strictly follow the application procedure as failure to do so will lead to automatic disqualification. Only online applications through the link provided will be accepted. You will receive a notification in your email if your application and documentation have been successfully received.
N.B: You will be required to present certified copies of your academic documentation before employment and so are advised to embark on the certification process soon enough to enable timely contracting.
The applications should be addressed to:
The Head of Human Resources,
MRC/ UVRI and LSHTM Uganda Research Unit,
P.O. Box, 49,
Entebbe, Uganda.


All Jobs

QUICK ALERT SUBSCRIPTION