Clinical Site Manager - Mbeya Tanzania - Africa

Our client is seeking a Clinical Site Manager to support the US Military HIV Research Program (MHRP) in Mbeya Tanzania.

The incumbent is responsible for being liaison on the ground for close follow-up of Military HIV Research Program (MHRP) activities in Mbeya, Tanzania. The incumbent will work closely with the site PIs and key clinic staff in carrying out responsibilities and providing feedback on clinical research activities to key MHRP POCs. The incumbent will facilitate information flow between various MHRP departments and counterpart National Institute of Medical Research-Mbeya Medical Research Center (NIMR-MMRC) POCs at the clinical research site. He/She will assist site and MHRP staff with the evaluation, development, set-up, training and monitoring NIMR-MMRC site’s participation in MHRP and HVTN clinical research studies. The incumbent will provide support and technical input for project plans including timelines, related to clinical, laboratory, pharmacy and data management operations to integrate activities with clinical trials and studies.

Clinical Site Operations
  • Conduct site qualification/evaluation on behalf of MHRP to assess feasibility to conduct studies/trials including review of staffing needs.
  • Work with the MHRP Clinical Operations Office (COO) Clinical Trials Specialist to map out regulatory strategies.
  • Facilitate the development, review and updating essential study documents and all aspects of documentation control and archiving.
  • Facilitate the implementation and management of assigned clinical studies including but not limited to: review of protocols and site-specific addendums, informed consent documents, recruitment documents, CRFs and questionnaires, training manuals, MOPs.
  • Develop and maintain liaisons with site PIs or designees to ensure proper and timely submissions to ECs and HAs, review and assist in preparation of appropriate responses for re-submission if necessary.
  • Facilitate communications with MHRP COO to ensure all regulatory documents required for DoD reviews are submitted in a timely manner; ensure all follow up submissions required for compliance are taking place.
  • Assist in preparation of study contact lists, workplans, study timelines and communication plans.
  • Hands-on review/development of source documents and other study tools.
  • Facilitate study mock-visits and other study start-up activities.
  • Assist in ensuring staff training records are maintained to include GCP, HSP, updated CVs, protocol training, and all DAIDS and Sponsor required training documentation.
  • Work closely with site PIs, site staff and protocol teams to ensure protocols and study related activities are conducted according to project timelines and in compliance with protocol and ICH GCP guidelines.
  • Anticipate and identify study’s critical path and communicate priorities to protocol teams on the ground and MHRP.
  • Review periodic study enrollment updates including recruitment, trial conduct and, if needed, identifying study-related problems and propose resolutions; update MHRP as required.
  • Facilitate proper reporting, follow-up internally and assist in management of Adverse Events (AEs)/Serious Adverse Events (SAEs) and other reportable events per protocol as needed. Ensure SAEs, safety update reports and other new information or sponsor reports are provided to and received by the sites for reporting to ethics, as needed.
  • Liaise with INLAP and site as needed to integrate lab activities with clinical trials and studies.
  • Liaise with DCAC and site to ensure that data queries are resolved, and to anticipate, identify, and/or solve other data management problems.
  • Liaise with pharmacist and protocol team to integrate pharmacy needs and requirements with clinical trial activities.
  • Participate in MHRP site and protocol team calls.
Monitoring and Quality Assurance
  • Assist site in preparing for upcoming monitoring and audit visits.
  • Conduct COO co-monitoring visits as needed.
  • Review monitoring and audit reports for tracking and trending of issues and escalate and participate in site training as required.
  • Work closely with clinic teams to ensure timely and appropriate follow-up of issues raised by monitors and Sponsor representatives.
  • Facilitate the development and/or updates to clinic quality management plans.
  • Conduct internal monitoring/QA activities to include review of select participants charts and provide feedback to teams.
  • Conduct internal regulatory reviews to ensure that regulatory documents are maintained and up-to-date and provide feedback to teams.
  • Ensure clinic teams are conducting QC/QA activities and compiling required reports for submission as required by DAIDS and other Sponsors.
  • Represent MHRP Clinical Directorate for any selected in-country collaborations as requested.
  • Follow-up on any required MHRP Clinical Trials Unit activities to include follow up on requests from NIH/DAIDS or HIV Vaccine Trials Network with regards to budgets, annual report preparation, monitoring findings, protocol and participant safety related queries, among others.
  • Facilitate and follow-up with site/study budget development as requested.
  • Facilitate in gathering data needed for determining study supply needs.
  • Facilitate site logistics planning to include but not limited to training, site visits, and travel as required.
  • Foster/arrange cross-site sharing of information and training.
Required Knowledge, Skills, and Abilities:
  • Knowledge of computers and Microsoft Office
  • Knowledge of Good Clinical Practices (GCP), Code of Federal Regulations and FDA guidance as it pertains to clinical research and monitoring.
  • A proven and successful track record in monitoring and management of investigational sites in large multi-center clinical trials preferred.
  • Experience in reviewing clinical trial data assuring accuracy, completeness and adherence to protocols and regulations/guidelines regarding good clinical practices.
  • Strong communication skills and proven ability for effective communication verbally, in writing, and through email.
  • Great attention to detail.
  • Ability to establish goals and agendas.
  • Self-motivated, resourceful with strong organizational skills and able to multi-task and work collaboratively and effectively in large, complex, multi-departmental, cross-functional teams.
  • Strong clinical project management skills preferred.
  • Diplomatic skills, excellent judgment and strong interpersonal skills needed.
  • Experience working in an international, multi-cultural setting desired.
  • Flexibility and willingness to travel to other field sites in Africa.
Minimum Education/Training Requirements:
  • BS/BA in a scientific, life sciences field or equivalent. Advanced degree, nursing degree or a Master’s degree in public health is highly desirable.
Minimum Experience:
  • 4 to 6 years of clinical trials experience.
  • Experience with HIV and/or vaccine clinical research trials, HIV related laboratory procedures, clinical safety laboratory testing desirable.
Physical Capabilities:
  • Frequent standing, sitting, walking, lifting, and travelling.
Required Licenses, Certification or Registration:
  • CCRA or CCRP certification highly recommended but not required.
Work Environment: Primarily office but also laboratory, clinic or hospital environment as position is based full-time in Mbeya, Tanzania.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources

NAFASI ZA KAZI MBEYA - 12/30/2016 NAFASI ZA KAZI MBEYA - 12/30/2016 Reviewed by Kazi Bongo on 4:38:00 AM Rating: 5


Tanzania Kenya NGO JOBS Uganda Best Jobs Consultancy Rwanda ICT JOBS Administrative United Nations Sudan Best Jobs Finance Health - Medical Engineering Ethiopia Education Agricultural Lecturer Human Resources Somalia Media Congo - Kinshasa Legal Jobs Bank Jobs Monitoring and Evaluation Mining World Vision Burundi Procurement Accountant African Barrick Gold Zambia Sales and Marketing US EMBASSY East African Community Mozambique Telecoms Research CARE International Save The Children Plan International Arusha Malawi South Sudan Oxfam Scholarships African Development Bank Finance and Administration SafariCom Aviation The Commonwealth American Embassy Sales Zanzibar Environmental Catholic Relief Services Dar es salaam USAID Operations FHI 360 UNDP Security World Bank Economist TradeMark East Africa Unicef Hospitality Managers International Rescue Committee (IRC) Restless Development Accounting Civil Engineers AMREF Morogoro Utumishi AfDB African Development Bank COOPI - Cooperazione Internazionale Driver - Logistics Path International Mwanza African Union Tigo Jobs Marketing Mbeya Teaching Au African Union PSI Population Services International Pwc PricewaterhouseCoopers East African Breweries North Mara Gold Mine ACTED Djibouti Malaria Consortium Bulyanhulu Gold Mine DFID Driver Buzwagi Gold Mine Jhpiego COMESA FINCA JOBS International Jobs Adeso Danish Refugee Council Kilimanjaro Nairobi Coca-Cola Handicap International Pact International Rio Tinto Solidarités International Tender EGPAF Elizabeth Glaser Pediatric AIDS Foundation Logistics Serengeti Breweries Ltd Nation Media Group Africare Norwegian Refugee Council Samaritan's Purse Chemonics International COUNTRY DIRECTOR ICAP of Columbia University InterShips Precision Air RwandAir Marie Stopes International (MSI) Serengeti Breweries Volunteer Climate Change IGAD Tetra Tech ARD Agriculture Jobs Dodoma Iringa One Acre Fund Project Management Clinton Health Access Initiative (CHAI Technoserve Twaweza East Africa ActionAid Lutheran World Federation SADC Secretariat Tanga Vso International ACDI/VOCA Halmashauri Agha Khan Kenya Commercial Bank World Agroforestry Centre Deloitte East Africa International Organization for Migration (IOM) COMESA Secretariat: Software Engineering Safety and Security Shinyanga Jobs Tanzania Breweries Pathfinder International World Health Organization KPMG TANROADS Tanzania Electric Supply Company British Council Futures Group KCB BANK UN-Habitat WFP World Food Programme Barclays GEITA GOLD MINING TANESCO Electrical Engineer Food and Agriculture Organization GOAL Mombasa Tabora WWF World Wide Fund for Nature Microsoft Tanzania Ports Authority East African Development Bank Family Health International (FHI) IBM EAST AFRICA IntraHealth International Mercy Corps SERIKALINI - GOVERNMENT OF TANZANIA AccessBank Community Development Jobs Data Base Management Google Africa ICAP - TZ KEMRI/CDC Program WaterAid Tanzania Auditor SNV International Stanbic Bank Amnesty Horn Relief Kampala Management Systems International (MSI) Standard Chartered Bank VETA Christian Aid DIAMOND TRUST BANK Helen Keller International Help Age Mtwara Uganda Telecom Airtel Africa Equity Bank Internships Marie Stopes TCRA Web Development B B C WORLD SERVICE Human Rights Kigali Makerere University Nile Basin Initiative Kenyatta University Kigoma Mzumbe University NSSF National Social Security Fund Nile Breweries Limited Tulawaka Gold Mine University of Nairobi kenya Airways Bank of Tanzania Graduates MTN Muhimbili National Hospital Nepad Partners in Health Room to Read SUMATRA UNWOMEN African Wildlife foundation (AWF) KEMRI Kagera Librarian MENTOR Initiative Trainee USAILI - INTERVIEW Uiversity of Nairobi WaterAid International icipe Project CAFOD - Catholic Agency for Overseas Development Egerton University EngenderHealth Goal Ireland Kenyan Banks Lake Victoria Basin Commission Peace Corps TANAPA TASAF Tanzania Social Action Fund Zanzibar University ACB AKIBA COMMERCIAL BANK AGRA Alliance for a Green Revolution in Africa Advans Bank Ethiopian Airlines Freedom House IITA International Institute of Tropical Agriculture Legal Moshi NMB BANK Resolute Tanzania Singida Uganda Uganda National Roads Authority University of Dar es salaam University of Dodoma British High Commission ChildFund EWURA FilmAid International NECTA TPDC Tanzania Civil Aviation Authority (TCAA) United States International University World Concern Aga Khan Foundation CBA Commercial Bank of Africa Ecomist Ernst and Young IUCN International Union for Conservation of Nature International Medical Corps Islamic Relief Kakira Sugar Musoma National Institute for Medical Research OPEN UNIVERSITY OF TANZANIA Relief International TAA Tanzania Airports Authority Trócaire Uganda Revenue Authority VODACOM TANZANIA VSF Belgium Architects Hivos IFC International Finance Corporation Ifakara Health Institute Inoorero University International Commercial Bank Kenya Red Cross Society MADEREVA Medical Oil and Gas Pwani University College SOKOINE UNIVERSITY Tumaini University Water Engineering AWF African Wildlife Foundation Acacia Mining Accounts African Virtual University Altima Africa Ardhi University Bank of Uganda Business Development Concultancy Del Monte Kenya Embassies Kenya Airports Authority Lake Victoria South Water Services Board Mara National Bank of Commerce RECORDS MANAGEMENT JOBS RUKWA Ruvuma Search for Common Ground Songea TTCL Tanzania Telecommunications Company Limited Unilever War Child International Zinduka Afrika ACORD AKU ​Aga Khan University Africa Nazarene University Africa Rice Center (AfricaRice) Aga Khan Health Services CRDB BANK Commercial Bank of Africa Daraja Tanzania Engineers Registration Board (ERB) Fina Bank International Potato Center International Potato Center (CIP) Intrahealth Jomo Kenyatta University Kilimanjaro Christian Medical Centre Kyambogo University Lindi Jobs MCL Mwananchi Communications MUHAS-harvad Moi University NBC BANK National University of Rwanda Ngorongoro Conservation Area Authority Njombe Nuru International Nzoia sugar Company RTI International SUA SOKOINE UNIVERSITY OF AGRICULTURE THE LAW SCHOOL OF TANZANIA TRA Tanzania Revenue Authority Tanzania Postal Bank The Foundation For Civil Society Udhamini wa Masomo Western Union AIR TANZANIA Action Against Hunger (ACF) Agricultural Society of Kenya BRALIRWA Bondo University College Caritas Comoros Concern Worldwide Conservation Jobs Consolidated Bank of Kenya DHL Express Ewaso Ngiro South River Basin Development Authority Geologist Gulf African Bank INSTITUTE OF ADULT EDUCATION Jomo Kenyatta University of Agriculture and Technology Kabale University Kabale University (KAB) Kenya Ports Authority KickStart International MORUWASA Morogoro Urban Water and Sanitation Authority MSH Management Sciences for Health Mumias Sugar Company Nairobi Hospital Nkumba University Rural Electrification Agency SOKINE UNIVERSITY SONGWE STAMIGOLD Stores TACAIDS TARURA TCU Tanzania Commission for Universities Tullow Oil World Lung Foundation (WLF) ALAF Limited Aga Khan Development Network (AKDN) Aga Khan Hospital Air Malawi American Refuge Committee BENKI YA POSTA - TPB BANK BTC Belgian Technical Cooperation B of Tanzania Bioversity International CHF International Customer Service Jobs DANGOTE DIT DAR ES SALAAM INSTITUTE OF TECHNOLOGY Danida Dar es Salaam Institute of Technology Daystar University ECOBANK ETDCO Electrical Transmission and Distribution Construction and Maintenance Company European Union IFM INSTITUTE OF FINANCE MANAGEMENT INSURANCE JOBS - BIMA ITECH Internews® Network KUITWA KAZINI Kenya Accreditation Service Kenya Polytechnic University College Kilombero Sugar Company Kisii University College Kisumu Laboratory Jobs MSD MEDICAL STORES DEPARTMENT MSF Switzerland Management Sciences for Health Manyara Maseno University Ministry of State for Planning Muteesa 1 Royal University Médecins Sans Frontières NIDA National Identification Authority Narok University College OSHA Occupational safety and Health Authority Open Society Initiative for Eastern Africa (OSIEA) PA PAC PEPSI POLICE - POLISI Petroleum EngineerS RWANDA HOUSING AUTHORITY Seychelles Songas TBC TANZANIA BROADCASTING CORPORATION TBS TANZANIA BUREAU OF STANDARDS TFDA TANZANIA FOOD AND DRUGS AUTHORITY TIB - Tanzania Investment Bank Tanzania Mortagage Refinance Company Tanzania Teachers’ Union Transmara Sugar Company Tropical Pesticides Research Institute Tumba College of Technology Twiga Cement UNESCO UNOCHA Umma University University WRP Walter Reed Project ZANTEL ao uga
Powered by Blogger.