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Clinical Research Project Manager

Kampala, Central Region, Uganda
October 20, 2018

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P. O. BOX *****


Telephone: +256-***-****** / +256-***-****** / +256-***-****** Email: / / EDUCATION

March 2003 – 2005 Research Fellow

Child Health Evaluative Sciences Department,

Research Institute,

Hospital for Sick Children, Toronto, Canada

Sept 2000- Dec 2002 Master of Science, Epidemiology Public Health Sciences Department,

University of Toronto, Canada

x Thesis: Prevalence and risk factors for drug resistant tuberculosis at an urban hospital in Uganda

June 1989 – Jan 1995 Bachelor of Medicine and Bachelor of Surgery (MB.ChB) Makerere University, Uganda


Microsoft Office (Word, Excel, Powerpoint, Access and Project). Proficient in data management and analysis using Access, SAS, SPSS, STATA, R and EPIINFO statistical packages. Familiar with the internet and searching electronic databases such as medline, pubmed and EMBASE for literature. Experience with reference software Endnote and Reference Manager


Course: Projects in Controlled Environment (PRINCE2) NEWPLAN Uganda,

July-Nov 2012, Kampala, Uganda

Course: Publication Workshop

Vienna School of Clinical Research,

8-15 Feb 2012, Capetown, South Africa

Course: 12th Advanced Vaccinology Course (ADVAC)

Fondation Merieux

16-27 May 2011, Annecy, France

Course: Trial Site Management

Vienna School of Clinical Research,

9-13 May 2011, Capetown, South Africa

Course: 20th Erasmus Epidemiology Summer Program

Erasmus University,

9-27 August 2010, Rotterdam, Netherlands

Course: Modelling of Infectious Diseases

Imperial College,


9-23 September 2010, London, UK

Course: Advanced Good Clinical Practice

Vienna School of Clinical Research,

21-23 March 2010, Nairobi Kenya

Course: Project Management in Clinical Research

Vienna School of Clinical Research,

18-20 March 2010, Nairobi, Kenya

Course: Protecting Human Research Participants

National Institute of Health (NIH) Office of Extra Mural Research, 17 June 2009, Web-based course

Course: Project Monitoring and Evaluation

Infectious Diseases Institute,

18-22 August 2008, Kampala, Uganda

Course: Fundamentals of Project Management

Project Management for Non-Government Orgs. (PM4NGOS), 14-20 June 2008, Kampala, Uganda


October 2013-Current Senior Scientist/ Project Leader/Clinic Manager Medical Research Council (MRC)/Uganda Virus Research Institute (UVRI)

Plot 50-55 Nakiwogo Road, Entebbe, Uganda

x Takes responsibility for overall coordination of the MVA85A clinical trial.

x Maintain and update the Investigator Master File (IMF). x Liaise and track correspondence with Ugandan and relevant foreign research ethics committees, regulatory and drug authorities and maintain communication with these bodies as needed

x Contribute to development of protocol and study tools x Ensure compliance with protocols and ICH/GCP

x Assist in review of protocol documents at site

x Design, maintain and assist with updates of the SOPs and compliance with SOPs

x Attend teleconferences and meetings as needed

x Liaise with study monitors

x Liaise with laboratory staff, data and statistical department x Oversee and review all field activities

x Supervise and train project personnel

x Review goals and evaluate all staff for competence x Ensure order/purchase of all study supplies

x Delegate responsibilities to appropriate qualified staff x Participate in interviewing and care of participants x Prepare regular reports


x Participate in writing papers for conferences and publications

x Participate in planning and budgeting

x Review monthly project expenses

x Attend and contribute to monthly Science Meetings and Science Seminars


Dec 2012 – Dec 2013 Independent Consultant Project Coordinator Johns Hopkins School of Bloomberg University, Center for Communication Programs. Plot 15 Binayomba Road, Bugolobi, Kampala, Uganda.

Contracted to coordinate survey, analyse data and write reports for Evaluation of Long Term Family Planning Methods for Marie Stopes Uganda and Health Facility Assessment for Stop Malaria Project

x Preparing study implementation plan for the facility assessments

x Preparing data collection mapping routes

x Developing field manuals and guides for interviewers, supervisors and quality control officers

x Co-facilitating training for research staff and making all logistical arrangements for the training

x Preparing and managing budget for the data collection x Preparing all logistics for the field work

x Monitoring of the field work

x Prepare a post-fieldwork report

x Monitoring and supervising data collection and entry x Maintaining contact with research teams and ensure they have adequate resources and instruments

x Ensuring good quality data entry and analysis

x Analysing survey data using STATA and

x Preparing a technical research report

x Presentation and discussion of study findings to funders x Perform secondary analysis from the Uganda Demographic and Health Survey

Full time employment

Aug 2007 – Sep 2012 Project Manager

Uganda TB Vaccine Preparation Studies,

Infectious Diseases Institute and Iganga/Mayuge Demographic Surveillance Site,

Makerere University College of Health Sciences, Kampala x Writing up study protocol

x Determining positions required to run the project x Developing the job descriptions and hiring the staff x Determining, procuring, allocating and managing project logistics and resources

x Developing study tools including informed consent forms, standard operating procedures (SOPs), case report forms, data collection tools,


x Preparing and submitting study documents for

ethics/regulatory approval and amendments

x Day-to-day coordination, project management and guidance of a team of over 40 staff

x Monitoring and evaluation responsibilities including developing, monitoring and evaluating of the project work plan

x Training and providing technical expertise particularly on tuberculosis, clinical research and epidemiological concepts to the team

x Preparing and submitting study reports to funders x Networking and liasing with both local stakeholders and international collaborators

x Supervising data cleaning processes and doing the data analysis

x Writing and preparing manuscripts for publication x Presenting and sharing findings at scientific meetings x Preparing and submitting new grants

Mar 2005 – July 2007 Research Associate/Project manager Project manager- Primary Care Asthma Pilot Project (PCAPP), Child Health Evaluative Sciences Department,

Research Institute,

Hospital for Sick Children, Toronto

March 2003-2005 Research Fellow

Child Health Evaluative Sciences Department,

Research Institute,

Hospital for Sick Children, Toronto

x Managing, implementing and coordinating a community- based project entitled the Primary Care Asthma Pilot Project in 8 primary care sites in Ontario

x Designing and implementing a provincial Occupational Asthma Surveillance Project

x Participating in the designing and development of study tools, questionnaires and serious adverse event reporting forms. x Responsible for the management and analysis of data from eight primary care sites across Ontario Province.

x Preparing monthly reports on status of study recruitment. x Preparing presentations and reports for scientific meetings and conferences

x Writing grants and preparing manuscripts for publication. x Site visits for monitoring study progress at external sites. x Chart abstraction review studies

x Assist in the teaching and supervision of junior students x Managing an interdisciplinary research team

Mar 1998-Aug 2000 Clinical Research Coordinator


Tuberculosis Research Unit,

Mulago Hospital Kampala, Uganda

x Coordinated various TB/HIV clinical trials

x Screening patients for study eligibility and enrolment x Participated in interviewing, investigating and diagnosis of new patients for ongoing studies

x Supervised and collected specimens from study participants in ongoing clinical trials

x Providing clinical care to patients

x Recruited patients into studies after reviewing clinical and laboratory information

x Abstracted data from patient’s hospital files to case report forms

x Identified missing or abnormal laboratory findings and followed them up

x Compiled and reported adverse events for patients in clinical trials

x Monitored and followed up adverse events up to resolution x Prepared weekly progress reports on study eligibility and enrolment

x Presented monthly presentations to staff and principal investigator about study progress

x Prepared summarized synopsis and explained concepts of new studies for use by study staff

Jan 1997- Feb 1999 General Practitioner – Private practice PAL Clinic, Makindye, Uganda

x Running an owned private practice clinic

x Investigating, diagnosing and treating patients as out-patients Jan 1996- Feb 1997 Medical Officer

Marie Stopes Reproductive Health Clinics, Uganda

x Supervision and management of field outreach services x Provided reproductive health services to clients x Carried out surgical contraception for men and women x Did field outreach family planning services for clients in rural western Uganda

x Compiled monthly reports on clinic and outreach activities Jan 1996- Dec 1996 Hotel doctor

(Part time) Sheraton Hotel, Kampala

x Patient care for staff and their families

x Responded to medical emergencies and inquiries from guests 6

x Did medical examinations of new hotel staff

x Regular health inspection for hotel and staff

x Delivered monthly presentations on work place hygiene and infection control to hotel staff

June 1994- Dec 1995 Intern medical doctor

Nsambya Hospital, Uganda

x Conducted ward rounds on medical and surgical wards x Did rotations in medicine, surgery and obstetrics units x Did 6-month rotation in paediatric clinics and wards x Run outpatient medical, diabetic, and surgical clinics x Worked in emergency surgical and obstetric operating theatres


Aug 2000 – Dec 2002 Canadian Commonwealth Scholarship July 2002 John Hastings Research Award

Dec 2003 Best Poster Award, Research Fellow’s Day, Hospital for Sick Children

Aug 2016 Medical Research Council PhD Training Fellowship PUBLICATIONS

1. Wajja A, Kizito D, Nassanga B, Nalwoga A, Kabagenyi J, Kimuda S, Galiwango R, Mutonyi G, Vermaak S, Satti I, Verweij J, Tukahebwa E, Cose S, Levin J, Kaleebu P, Elliott AM, McShane H. The effect of current Schistosoma mansoni infection on the immunogenicity of a candidate TB vaccine, MVA85A, in BCG-vaccinated adolescents: an open-label trial. In press. Accepted by PLoS NTDs for publication in April 2017

2. Ssengooba W, Gelderbloem SJ, Mboowa G, Wajja A, Namaganda C, Musoke P, Mayanja-Kizza H, Joloba ML. Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource- limited setting: an experience from Uganda. Health Res Policy Syst. 2015 Jan 15;13:4.

3. Nabongo P, Verver S, Nangobi E, Mutunzi R, Wajja A, Mayanja-Kizza H, Kadobera D, Galiwango E, Colebunders R, Musoke P. Two year mortality and associated factors in a cohort of children from rural Uganda. BMC Public Health. 2014 Apr 5;14:314.

4. Lutwama F, Kagina BM, Wajja A, Waiswa F, Mansoor N, Kirimunda S, Hughes EJ, Kiwanuka N, Joloba ML, Musoke P, Scriba TJ, Mayanja-Kizza H, Day CL, Hanekom WA. Distinct T-cell responses when BCG vaccination is delayed from birth to 6 weeks of age in Ugandan infants. J Infect Dis. 2014 Mar;209(6):887-97. 7

5. Waako J, Verver S, Wajja A, Ssengooba W, Joloba ML, Colebunders R, Musoke P, Mayanja-Kizza H. Burden of tuberculosis disease among adolescents in a rural cohort in Eastern Uganda. BMC Infect Dis. 2013 Jul 26;13:349. 6. Asiimwe BB, Bagyenzi GB, Ssengooba W, Mumbowa F, Mboowa G, Wajja A, Mayanja-Kiiza H, Musoke PM, Wobudeya E, Kallenius G, Joloba ML. Species and genotypic diversity of non-tuberculous mycobacteria isolated from children investigated for pulmonary tuberculosis in rural Uganda. BMC Infect Dis. 2013 Feb 18;13:88.

7. Ssengooba W, Kateete DP, Wajja A, Bugumirwa E, Mboowa G, Namaganda C, Nakayita G, Nassolo M, Mumbowa F, Asiimwe BB, Waako J, Verver S, Musoke P, Mayanja-Kizza H, Joloba ML. An Early Morning Sputum Sample Is Necessary for the Diagnosis of Pulmonary Tuberculosis, Even with More Sensitive Techniques: A Prospective Cohort Study among Adolescent TB-Suspects in Uganda. Tuberc Res Treat. 2012;2012:970203.

8. Hatherill M, Verver S, Mahomed H; Taskforce on Clinical Research Issues, Stop TB Partnership Working Group on TB Vaccines. Consensus statement on diagnostic end points for infant tuberculosis vaccine trials. Clin Infect Dis. 2012 Feb 15;54(4):493-501.

9. Buregyeya E, Kulane A, Colebunders R, Wajja A, Kiguli J, Mayanja H, Musoke P, Pariyo G, Mitchell EM. Tuberculosis knowledge, attitudes and health-seeking behaviour in rural Uganda Int J Tuberc Lung Dis. 2011 Jul;15(7):938-42 10. Hertoghe T. Wajja A. Ntambi L. Okwera A. Aziz MA. Hirsch C. Johnson J. Toossi Z. Mugera R. Mugyenyi P. Colebunders R. Ellner J. Vanham G. T cell activation, apoptosis and cytokine dysregulation in the (co)pathogenesis of HIV and pulmonary tuberculosis (TB) Clinical & Experimental Immunology. 122(3):350-7, 2000 Dec.

11. Mayanja-Kizza H. Wajja A. Wu M. Peters P. Nalugwa G. Mubiru F. Aung H. Vanham G. Hirsch C. Whalen C. Ellner J. Toossi Z. Activation of beta-chemokines and CCR5 in persons infected with human immunodeficiency virus type 1 and tuberculosis. Journal of Infectious Diseases. 183(12): 1801-4, 2001 Jun 15. 12. Mayanja-Kizza H. Johnson JL. Hirsch CS. Peters P. Surewicz K. Wu M. Nalugwa G. Mubiru F. Luzze H. Wajja A. Aung H. Ellner JJ. Whalen C. Toossi Z. Macrophage- activating cytokines in human immunodeficiency virus type 1 – infected and – uninfected patients with pulmonary tuberculosis. Journal of Infectious Diseases. 183(12): 1805-9, 2001 Jun 15.

13. To T, Wajja A, Wales PW, Langer JC. Population Demographic Indicators Associated with Incidence of Pyloric Stenosis. Archives of Pediatric & Adolescent Medicine. 2005 Jun;159(6):520-5

14. Borenstein S, To T, Wajja A, Langer J. Effect of subspecialty training and volume on outcome after pediatric inguinal hernia repair. Journal of Pediatric Surgery. 2005; 40 (1): 75-80.



x Centre Member, Makerere University-Uganda Virus Research Institute Infection and Immunity (MUII-plus) Centre of Excellence

x Member, Canadian Society for Epidemiology and Biostatistics x Member, Canadian Public Health Association

x Member, Uganda Medical Association

x Member, Uganda Women Medical Doctors’ Association

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