Supervisor Medical Data Entry (EndTB Trial) (BB-D96DE)
Found in: Talent IN
Description:Background Doctors Without Borders/ Medecins Sans Frontieres (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, natural and man-made disasters and exclusion from healthcare in more than 70 countries. DWB offers assistance to people in need and irrespective of race, religion, gender or political affiliation. Doctors Without Borders has worked in India since 1999, providing free-of-charge essential healthcare to people in remote areas; treatment and care for people affected by HIV/AIDS, malnutrition; hepatitis C, tuberculosis, kala azar and sexual and gender-based violence; an important subject for our action is containing effect of antibiotic resistance. We also respond to natural disasters and other emergencies, provides mental healthcare and advocates for the development of more effective and affordable medicines to improve access to treatment everywhere. Doctors Without Borders was awarded the Indira Gandhi Prize for Peace, Disarmament and Development in 1996 and the Nobel Peace Prize in 1999. Doctor Without Borders India (DWBI) runs projects in the states of Andhra Pradesh, Bihar, Chhattisgarh, Delhi, Jammu and Kashmir, Jharkhand, Maharashtra, Manipur, and Telangana. Doctors Without Borders India (DWBI) and the endTB project Doctors Without Borders, and its partners i.e. Partners In Health (PIH), Interactive Research and Development (IRD), Epicentre, France, Institute of Tropical Medicine, Belgium and the Harvard Medical School have launched two major clinical trials, endTB and endTB-Q which seek to revolutionize treatment for the toughest strains of tuberculosis (TB), the worlds leading infectious disease killer. The goal of these studies is to generate high quality evidence from a highly heterogeneous population that could lead to a change in the global recommendations for the management of MDR-TB. The endTB trials are multi-country, randomized, controlled, Phase III clinical trial testing five new, all oral, shorter duration regimens compared to the current standard of care. The aim of the trials is to find shorter, less toxic and injection-free treatments for multidrug-resistant TB (MDR-TB). The experimental regimens mainly rely on newly approved or repurposed drugs and avoid drugs to which high rates of resistance have been reported in MDR-TB patient populations. These multicountry trials are being conducted in Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa and Vietnam. In India the trials are conducted at Mumbai and Pune sites by Doctors Without Borders India (DWBI) in Partnership with ICMR- National AIDS Research Institute (NARI) and in support with National Tuberculosis Elimination Program (NTEP). General Location Pune, Maharashtra Availability 12 Months (Renewable) Last application date 22th July 2020 Starting date 1st August 2020 Email msfocb- Main Tasks & Responsibilities Undergo training in the protocol, trial procedures, and GCP and rules prescribed by local NRA. Perform corrections in the eCRFs upon request of the quality manager or study coordinator In consultation with site PI enter the treatment outcomes from the source document in the eCRF Support the site clinical investigator or the delegated site clinician with data recording and entry into the eCRF Assist to define the monitoring strategy of the project according to the changing medical needs and context. Strategic data management support to the project in Pune Ensure quality and timeliness of routine and ad-hoc reports, queries, and extracts as required. Strengthening the quality of data collection and reporting, in close collaboration with data entry operators and medical teams. Support the data process/management strategies, used by stakeholders involved in endTB projects and interventions. Support data collection and management of the routine monitoring and additional data collection required for OR and routine reporting. Ensure that the data collection is streamlined with the needs of the endTB project as required. Line management of Data entry operators in end TB trial project by following up on their leaves, trainings and other issues. Participate in the team planning for the trial implementation and monitoring of the trials performing additional activities whenever needed and as requested by the site coordinator. Managing the daily flow of the trial documents at site and ensuring all source documents are collected and filed properly Implementing quality control procedures and guidelines. Maintain and upgrade the equipment used for database management as per the guidance of central endTB trial team. Assist with identifying and maintaining digital security systems to safeguard sensitive data. Requirements Specific Skills Ability to organize and prioritize workload & taking initiative when appropriate Able to integrate into a multi-cultural team and cooperate with co-workers Able to work independently as well as part of a team and ability to cope with stress. Ability to act with responsibility Demonstrates flexibility in taking up tasks outside of regular job responsibilities as required Aptitude for humanitarian medical work. Excellent reporting skills. Languages English , Local Languages (Hindi & Marathi are essential). Qualifications Bachelors degree in Science /Health sciences/ Pharmacy/ Medical sciences , Postgraduate degree / diploma in clinical data management will be preferred Experience Essential, working experience of at least 2-3 years in related jobs.(Clinical data management, clinical research) Experience in clinical trial site / CRO will be an advantage HR & Benefits (non-negotiable) Monthly Gross Salary INR 38,890 and Secondary Benefits as per policies 13th Month Salary/ Festival Bonus 18 Annual Leaves 12 Casual Leaves Other compassionate leaves Medical Reimbursement including dependents Application Procedure To apply, please email your CV and motivation letter with the subject Ref Supervisor Medical Data Entry to msfocb- by 22nd July 2020 500 pm. ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW.
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