Medicines/Vaccines Manager at Medical Research Council (MRC) Unit The Gambia

Medical Research Council (MRC) Unit, The Gambia – We are the leading research centre in sub-Saharan Africa, carrying out internationally competitive research into tropical medicine for over 50 years. Our current research agenda focuses on three themes: Disease Control & Elimination; Nutrition; Vaccines & Immunity. Looking towards the future. we are aiming to push forward into new and challenging areas reflecting changes in national and global health priorities.

Applications are invited for the position below:

Job Title: Medicines/Vaccines Manager

Location: Fajara
Grade:3, 27 Points.

Introduction
The Medical Research Council Unit The Gambiaat the London School of Hygiene and Tropical Medicine, has an international reputation for ground-breaking research into some of the leading causes of morbidity and mortality in the tropics. Achievements include a large trial showing the efficacy of Haemophilus influenzae type b vaccine in The Gambia and the subsequent near elimination of the disease, pioneering work on the impact of insecticide treated bed nets as a preventive measure against malaria leading up to their worldwide use, and studies demonstrating the impact of conjugate pneumococcal vaccines on pneumonia and child mortality. This Unit has also undertaken alarge number of clinical vaccine trials many of which have had a direct impact on vaccine schedules globally.

To reflect changes in national and global health priorities a new research portfolio has been organized under three themes: Vaccines and Immunity, Nutrition and Disease Control & Elimination. Research in these themes seeks to target health needs of people in West and sub-Saharan Africa, to reinforce sub-regional and international collaborations and to address some of the major current priorities formulated in the WHO Sustainable Development Goals.

The Unit has world-class facilities for undertaking field, clinical and laboratory research. A diverse range of clinical trials and other field and laboratory research are currently being undertaken at the Unit. Within the Vaccines and Immunity Theme we are currently undertaking a significant number of clinical vaccine trials including early phase (1/2) trials as well as phase 3 licensure and phase 4 post licensure studies. All trials are conducted according to ICH-GCP aiming to attain the highest international standards.

We currently have several ongoing maternal vaccination studies as well as licensure trials for new vaccines and various trials aiming to optimise vaccination schedules. Clinical trials in addition provide medical care for study participants, usually at the trial sites located within or close to the premises of a government health facility, or at the Clinical Services Department (CSD) in Fajara. Provision of said care requires maintenance of a pharmacy within the trial sites that is stocked to address the common illnesses expected within the trial population demographic, as well as anticipated emergencies.

The post-holder will be based at the MRCGat LSHTM Fajara although may be required to work in other parts of The Gambia.

Purpose of the Job

The post-holder will support several vaccine trials and other studies ongoing at the Unit. They will have a key role in supporting the principal investigator and clinical trial coordinators in these trials.
They will work closely on a daily basis to support experienced clinical trial officers/senior nurses who have until now taken all responsibilities for vaccine management.
Key tasks will include liaison with vaccine suppliers and external sponsors to ensure vaccine shipments are effectively coordinated, overseeing vaccine receipt from international shipments, cold chain monitoring and recording, vaccine accountability and vaccine stock management.
They will work closely with internal and external clinical trial monitors and auditors both during site visits and by e-mail to resolve any discrepancies. They will also play an important role in the management of other medicines which may be provides to participants in trials (for example – associated with adverse events) to ensure effective stock management.
Based on the experience of the applicant it is also hoped they will also work to develop ongoing quality improvement strategies for clinical trials and will provide training to other members of the team on best practice.

Role
The post-holder will carry out the following:

Oversee and quality check all vaccine accountability processes and ensure any discrepancies are rapidly resolved.
Manage all vaccine stock levels to minimise wastage though vaccine passing their expiry dates.
Assist in the monitoring of the vaccine cold chain both during vaccine shipment, storage, and transport to field sites.
Work with external sponsors, monitors and auditors to a high professional standard
Work with officials from the Ministry of Health and Social Welfare (MoHSW), Expanded Programme on Immunization (EPI) and other relevant government bodies to ensure compliance of clinical trials with applicable agreements and regulations – this may include working with the clinical trial support office on import authorization and clinical trial authorization submissions to the national regulatory authorities
Undertake all their work to ICH-GCP standards and applicable best practice related to vaccine and medicine management
Maintain all required documents related to investigational products in the investigator site file/trial master file.
Develop new, innovative, quality improvement procedures to further reduce error
Write standard operating procedure (SOP), study specific procedures (SSP) and other clinical trial documents related to vaccine and drug handling
Provide input into the writing of clinical trial protocols in the area of vaccine management.
Train other members of the clinical trial team
Manage medicine stock levels at field site in liaison with site nurse coordinators
Provide support to other members of the clinical trial team
Work independently and with initiative while communicating and concerns to senior members of the clinical trial team rapidly and effectively
Assist with randomization processes in the field as required.
Ensure clinical trials have a continuous supply of required medications. This will include working with the CSD Medicines Manager, Procurement and Stores staff to ensure adequate stocks of commonly prescribed medications and identified emergency drugs are available for the duration of the trial, and updating the Unit clinical formulary to include items for which there is a foreseeable long-term demand
Working with clinical trial teams to ensure continuous improvement in stewardship of supplied drugs. This will include assisting with a forecast of medication demands for trial duration and placing drug stock orders at trial start-up; monitoring consumption trends during the trial with a view to optimising usage and minimizing wastage; advising on improved prescribing practices among clinical staff; providing clinically relevant updates on items in the formulary e.g. updated indications or side effects information for drugs in stock; and addressing miscellaneous challenges in therapeutics such as pediatric dosing of medications for which child-friendly formulations are unavailable or reviewing options for treatment of rare illnesses.

Relationships:

The post-holder will report to Ed Clarke, Principal Investigator, Vaccine and Immunity Theme
The post-holder is a full-time member of the MRC staff.
The Theme Leader of the Vaccine and Immunity Theme is Professor Beate Kampmann
The Unit Director is Professor Umberto D’Alessandro.
The Director of Operations is Mr Joan Vives Tomas.

Appraisals:

Appraisals are held at least annually.

Length of appointment:

The appointment is for 12 months initiallyand is subject to a probationary period of 6 months.

Any other duties:

To perform any other duties consistent with the remit of the post.

Essential Requirements

B.Sc in Pharmacy or a related area.
Substantial experience working in pharmacy, logistics or another relevant professional scientific area.
Some understanding and/or experience of working to ICH-GCP.
Good understanding of essential vaccine handling processes.
Excellent written and spoken English.
Excellent communication skills.
Computer literate in Word, Excel and Email.
Capacity to efficiently multi-task across several on-going projects simultaneously.
Proven experience of managing staff.
Willingness to work flexibly including at weekends on occasions.

Desirable:

Master’s degree in pharmacy, clinical trials or other directly relevant topic.
Experience of pharmacy work in clinical trials and/or clinical practice.
Experience of developing and maintaining drug formularies and of advising and overseeing clinicians prescribing practices.
Detailed understanding of vaccine accountability and cold chain management.
Other professional qualification in clinical trials.

Remuneration

The salary attached to the post is in Grade 3, 27 Points of MRC Unit The Gambia at LSHTM’s pay scale at a net monthly salary of GMD49,737. This converts to a take home pay of approximately $1, 002 per month using the prevailing Dalasi/USD exchange rate.
The package will also include furnished accommodation, flights, contribution to school fees for children and other benefits for displaced staff.
The appointment is for 12 months initially and will be subject to a probationary period of 6 months.

Application Closing Date
27th May, 2019.

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