Clinical Trial Manager Laboratory job at MRC/UVRI and LSHTM Uganda research Unit

MRC/UVRI and LSHTM Uganda research Unit

Clinical Trial Manager Laboratory job Post

Location: Jobs in Uganda 2022 - 2023

Work Hours: Full-time, 08 hours per day

Salary: UGX

No. of vacancies: 01

Deadline: 26 August 2022

Hiring Organization: MRC/UVRI and LSHTM Uganda research Unit

Job Details:

Clinical Trial Manager Laboratory

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

Job Purpose:
The position holder is to provide research support to the Principal Investigator, scientists,
statisticians, study coordinators, Project Leads, Data Managers, Programmers, and other trial
staff as part of the Trial team by undertaking the development and operational management
of the laboratory across some of the Unit’s clinical trials. The position works across disease
areas and some travel may be required.

Roles & Responsibilities
1. Principal duties;
• Producing trial documentation for laboratory procedures and sample collection, according to scientific requirements of the protocol and in line with the regulations and the Unit’s guidelines. This will include liaising with laboratories participating in unit studies for contract negotiation, budget maintenance, quotes, and assays, etc. as needed;
• Promoting trials and working with the trial teams to ensure wide participation and good accrual of patients and the successful coordination, and management of participant’s samples. This will include assisting in the production of newsletters, visiting sites, attendance at scientific conferences and meetings, and presenting information about the laboratory procedures, and requirements of the trials;
• Assist with developing programmes, agendas for regular team meetings, and possibly national and international meetings;
• Provide training, information, and advice to trial clinicians, research nurses and pharmacists, and laboratory staff on all laboratory protocol requirements for studies;
• Ensuring all essential documentation, including SOP’s covering laboratory procedures are up to date and in place at the CTU and trial sites in preparation for regulatory inspections and trial closure;
• This role will also take responsibility for on-site monitoring of laboratories, samples, and processes at the clinical sites, where necessary, to ensure that sites are following the protocol and relevant Good Clinical Practice/Good Laboratory Practice guidelines and any contract-specific requirements. This may involve writing reports and suggesting action to be taken to improve lab procedures and referring significant issues to the chief investigator or trial physicians;
• Coordinate the sourcing, purchasing, and delivery of the trial laboratory supplies, obtaining the best quotations for products where possible;
• Coordinating IATA training for laboratory staff working at the international trial specimen repositories as well as keeping their own certification updated. Liaising with sites to coordinate shipments and helping to prepare necessary customs and permits for import and export of clinical trial samples;
• Representing the Unit on laboratories procedures group teleconferences, contributing to the call, and any decisions. Helping with the development and improvement of written laboratories procedures and forms and making relevant trial teams aware of changes and completing tasks that result from the group;
• Main point of contact for Units’ central specimens’ repository; responsible for freezer updates, database maintenance of stored samples, and retrieving specimens for future studies when needed. Ensuring timely payment of invoices and requesting additional quotes for other trials needing to archive or store samples at the facility;
• Where required, to assist in unit audit processes; and,
• Any other duties appropriate to the grade assigned by the Project Lead or the Clinical Project Manager.

Person Specification
• University/Bachelor’s degree (or higher) in biomedical laboratory/or health-related field;
• Should possess recent experience in the conduct of clinical trials involving investigational medicinal products;
• Proven working experience in implementing GCLP/GCP;
• Experience working in clinical research;
• Experience working within the clinical trials environment;
• Experience in audit laboratory /sample management systems;
• Experience in study trial document development including protocols, CRFs, study
• reports, laboratory analytical plan, and Standard Operating Procedures;
• Recent experience of working in a laboratory
• Experience in 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.

Application procedure

Follow the link below to fill out a form and submit your application documentation: https://redcap.link/Clinical_Trial_Manager_Laboratory
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.