DIVISION OF INFECTION & IMMUNITY CLINICAL TRIAL FINANCE MANAGER (GRADE 7)
Background to the post UCL is performing an international trial of tuberculosis treatment that will, if successful be the first improvement in therapy for more than forty years. This is an unique opportunity for self-motivated; organized and competent individual to undertake a challenging task providing financial control of an exciting global project costing up to $30 milllion. The MRC Clinical Trials Unit is an integral partner in this study. The REMoxTB study is funded by the European Developing Country Clinical Trials Partnership, the Global Alliance for TB Drug Development and the Medical Research Council. Additional funds are being provided by the World Health Organisation, Bayer-Schering Health Care and Sanofi-Aventis. Moxifloxacin has been identified as a drug with the potential, in combination with other drugs, to shorten the duration of treatment for tuberculosis. In the Remox TB study we propose to investigate the ability of moxifloxacin to substitute for either ethambutol or isoniazid in the current standard treatment combination used to treat tuberculosis. We will trial a treatment combination substituting ethambutol with moxifloxacin, giving four months of treatment; and a treatment combination substituting isoniazid with moxifloxacin, giving four months of treatment; and comparing both to the international standard six month regimen. The REMox TB study is a double-blind, randomised, placebo controlled study. We will compare two, shorter, 4 month treatment combinations with the standard treatment combination of 6 months (Combination 1). In one of the shorter experimental treatment combinations, the antibiotic ethambutol is replaced by the trial drug moxifloxacin (Combination 2). In the other shorter experimental treatment combination, the antibiotic isoniazid is replaced with the trial drug moxifloxacin (Combination 3). A group of patients will receive standard 6 month treatment (Combination 1). There will be similar numbers of patients receiving all three treatment combinations and the cure rates and relapse rates will be compared. The REMoxTB trial is registered as an international trial (ISRCTN register, ISRCTN85595810) sponsored by UCL and it is being performed to the highest international regulatory standards. Ethical approval has been given by the UCL ethics committee and the local and national ethics committees at all our international sites. The results of the study will be published in specialised international journals so that other doctors and health workers can learn from this study and the international drug regulatory agencies can decide whether this is a useful treatment for tuberculosis. Clinical trials will take place in six sites initially and will expand to include further sites:
Kilimanjaro Christian Medical Center, Moshi, Tanzania (Headed by Principal Co-investigator Professor Noel Sam) The Unit for Clinical and Biomedical TB Research, Durban, South Africa (Headed by Principal Co-investigator Dr Roxana Rustomjee) University Teaching Hospital, Lusaka, Zambia (Headed by Principal Co-investigator Dr Peter Mwaba) University of Cape Town (Headed by Principal Co-investigator Dr Rod Dawson)
University of Stellenbosch (Headed by Principal Co-investigator Dr Andreas Diacon) Kenyan Medical Research Institute (Headed by Principal Co-investigator Dr Evans Amukoye)
Data management and analysis, project management and administration take place at:
UCL (Headed by the Chief Investigator Professor Stephen H Gillespie & Co-investigators Dr Tim McHugh and Professor Ali Zumla) MRC Clinical Trials Unit (Headed by Principal Co-investigator Professor Andrew Nunn, Dr Sarah Meredith and Project Manager Susan Tebbs)
1.
Reporting chain
The successful applicant will be accountable to the Professor Gillespie and will be line managed by Dr Tim McHugh. The post holder will integrate their activities with the UCL contracts office. The post will be held in the Research Department of Infection in the Division of Infection & Immunity.
2. Job Description The Clinical Trial Finance Manager will oversee all financial aspects of the trial. The postholder will be expected to:
Negotiate and finalise the financial aspects of site agreements in accordance with Trial policies and liaising with Divisional staff, UCL’s Contracts Office and the Joint Biomedical Research Unit, as necessary Set up and maintain standardised and auditable systems to ensure that site invoices are paid according to agreed timelines and in accordance with Trial policy Set and maintain auditable systems for authorising expenses Undertake routine financial analyses and provide regular management report and budget forecasting Ensuring that all activities are undertaken in accordance with the sponsor’s requirements and the funders terms and conditions Responsible for all financial management aspects of the trial: including invoice preparation and payment; authorising expenses; regular management reporting and budget forecasting Liaising with participant institutions to ensure that financial reports and claims are submitted in a timely fashion Liaising with relevant UCL Research Services regarding the regular recovery of funds from various funders Liaison with the MRC Clinical Trials Unit financial officers as necessary Liaise with the MRC CTU to ensure contracts meet the needs of the joint team. Provide financial information to assist with the preparation of future applications for funding to ensure the continuation of the project Communication with new sites to facilitate contract negotiations and participating in those to expedite the process and support the trial team Establish meetings and teleconferences to support the effective delivery of the trial
The post-holder will be expected to liaise with clinical and other scientific staff and to attend meetings and seminars, as appropriate. The postholder will be based in London but there may be a necessity to travel internationally on some occasions to complete contracts and liaise with funders. The postholder will be expected to carry out any additional duties as may reasonably be required within the general scope and level of the post. Key relationships The post holder will have regular contact with and will collaborate with the following groups - Divisional staff - Joint Biomedical Research Unit - UCL UCLH joint unit - UCL contracts office and UCL Finance Department - The Chief investigator, - MRC Clinical Trials unit Project manager, Trial Manager and monitoring team Laboratory Co-ordinator - Trials clinicians - International sites and the local Principal Investigators and local managers - International funding agencies - Contract Research Organisations supporting the trial - International Pharmaceutical Companies that are partners in the trial - International regulatory bodies
3. Person Specification REQUIREMENTS HOW CRITERIA E/D* ASSESSED ? AF/IV/T** 1. Education/Qualific ations/ Training 2. Skills/Abilities Good Bachelors degree, or equivalent Qualification or training in accountancy Highly numerate Excellent organisational skills Excellent communication skills (verbal & written) Meticulous attention to detail Ability to demonstrate initiative Excellent IT skills Strong negotiating skills E E AF/IV AF/IV E D AF/IV
E E E E
AF/IV AF/IV AF/IV AF/IV
3. Experience / Knowledge
Proven track record of financial management Proven track record of grant management and/or financial management of clinical trials Proven track record of contract preparation/review
E D
AF/IV AF/IV
D
AF/IV
4. Other requirements
Collaborative skills
E
IV
*AF=application form; IV = interview; T = test; *E- essential; D=desirable;