Data Analyst - Mumbai - Doctors Without
- Doctors Without
- 2 - 3 years
- Mumbai
- 3 years ago
- Email to a friend
- Report this job
Job Description
Vacancy: DATA ANALYST ACTIVITY MANAGER / INTERNAL MONITOR
No. of Vacancies - 1
Doctors Without Borders India
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, providingfree-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.
without Borders was awarded the Indira Gandhi Prize forPeace,Disarmamentand
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 andKashmir,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 multi-country 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).
Benefits (Non-negotiable)
Monthly Gross Salary: INR 69,882/- and Secondary Benefits as per policies:
13th Month Salary/ Festival Bonus
18 Annual Leaves
12 Casual Leaves
Other compassionate leaves
Medical Reimbursement including dependents
Personal Accidental Insurance including dependents
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.
Good Punctuality and ability to act with responsibility
Demonstrates flexibility in taking up tasks outside of regular job
responsibilities as required and aptitude for humanitarian medical work.
Excellent computer skills (especially MS Office MS Word and MS Excel) &
reporting skills.
Languages: English, Hindi & Marathi.
Qualification-
Desirable degree (or masters) in Medicine, Pharmacy or Health Sciences
with Diploma in Clinical Research.
Desirable specialization or training in tropical diseases Main Tasks & Responsibilities
Accountabilities :
With the support of the Desk Epidemiologist, creating, reviewing and adapting data collection tools according to
the project indicators and coordinating the development, implementation and follow up of Standard Operating
Procedures (SOPs) for documentation. Developing and implementing data quality assurance methods to ensure
good performance of the activities and reliability of the information, treating with respect and confidentiality all
patient information.
Providing technical support to the medical team and data entry staff in the implementation of routine data
recording, collection and entry for the selected project indicators in clinics and/or hospitals and/or health centers.
Organizing and implementing or providing technical support in the establishment of monitoring tools for new
activities as initiated in the project.
On a monthly, quarterly or basis of request, implementing detail analysis of recorder data for key indicators forthe
project in order to facilitate the definition, redefinition or reorientation of project activity. This will also include
analysis of the districts (MoH) cohort data, whenever available. Following the analysis, identifying and reporting
any new and interesting indicators for review with the medical team for potential follow up where relevant.
Managing and supervising the work of the data team personnel for quality assurance including identification of
training needs and providing coaching for the staff on issues related to data
Planning and supervising, with support of the HR department, the associated HR processes (recruitment,
training/induction, evaluation, potential detection, motivation,developmentandinternalcommunication) the data
team in order to ensure having the appropriate team in terms of size, capabilities and skills.
Participating in meetings and/or trainings as requested scheduled by manager or MSF. This includes but is not
limited to MSF internal meetings and/or trainings, and local, regional, or international meetings and/or trainings
On a monthly basis and in collaboration with the medical team, preparing and submitting summary reports on
analysed data for both MoH and MSF and preparing and implementing MSF internal monthly or quarterly medical
data presentation, including facilitation of team reflection and sharing of updates to promote teamdynamismand
reactivity.
Performing additional activities whenever needed and as requested by the supervisor
DWBI Section/Context Specific Accountabilities
In collaboration with the Sponsor and the Operational Research Coordinator, define QualityAssurance and Quality
Control activities on site
Review all trial documents to ensure they align with the latest version of the protocol and GCP
Submission of monthly reports to the Sponsor and the Operational Study Coordinator along with analysis
Follow up of implementation of all the Corrective Action and preventive Actions identified.
Undergo training in the protocol, trial procedures, and GCP
Review the Investigator Site File for the essential documents, regulatory and ethic committee sectionto ensure the
documents archiving completeness and submissions of protocol and protocol amendments, patients materials,
safety information and deviations are performed as per ICH-GCP, Indian GCP, Sponsor and local requirements
Review in collaboration with the Sponsor and the Operational Researchcoordinator the Worksheets andotherlocal
trial documents to ensure process consistency and adequacy of processes andinstruments usedfordata collection.
Ensure that the versions in use of study protocol, informed consent forms, guidelines, SOP, worksheets and any
other study related document are updated and that the staff is adequately trained on the latest versions.
Review participants clinical files, and perform Quality Assurance (QA) and Quality Control (QC) according to
parameters as indicated in the Site Quality Management Plan and specific SOPs. In specific, review participants
patients files to verify that patient care, safety reporting, drugs prescription andadministrationanddata collection
are performed according to locally established procedures and study protocol/SOPs/guidelines.
Review drug accountability documentation, pharmacy participants files and temperature/Humidity monitoring
records to ensure drugs are adequately received, stored and dispensed to the patients. Ensure that accountability
of returned/expired drugs is managed appropriately and unused drugs are destroyed as per local requirements.
Ensure quality of the data transmitted to the Sponsor is of a high standard (i.e. performing QCinsource documents
and source data verification in data entered in designated data tool).
Provide technical support to the field team and data entry staff in the implementation of routine qualityassurance
data recording, collection and entry for the selected indicators in the study sites. Organizing and implementing
technical support in the establishment of monitoring tools for quality assurance activities.
On a monthly, quarterly or basis of request, implement detailed analysis and report of recorded data in order to
facilitate the definition, redefinition or reorientation of quality of patient support and care including data
management. In particular identify corrective actions and preventive actions and follow-up on their
implementation.
Verify that the Informed Consent Forms are complete, dated ,and signed by the study personnel who obtained
informed consent and the patient, and, if applicable, the parent, guardian, or legal representative.
Verify that consent withdrawals have been properly documented
Review and monitor the Investigator Site File and Central Investigator File regularly for content and completeness.
Verify responses provided to data queries generated by the central Data Management team and by the external
monitor are accurate
Support the external monitor during the monitoring visits
Support the Operational Research Coordinator with review of submissions to Indian ERB andregulatoryauthorities
Assist with additional tasks as agreed upon with study management
Attend regular meetings with the endTB trial team.
Attend meetings related to the endTB trial, including at MSF, clinical, academic, and community forum.
Duration 12 Months (Renewable)
Location: Mumbai
Expected Start Date: 1 December 2020. STTo apply please email your CV and motivation letter with the subject Ref: Internal Monitor
To: ms**********i@br*****s.msf.org by 19th November 2020 5:00 pm.
ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW. www.msfindia.in
Job Classification
Industry: NGO, Social Services, Regulators, Industry AssociationsFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: Doctors WithoutAddress: 3rd floor, pitruchaya building, sanghavi corporate park, near wasan motors, govandi east , mumbai - 88
Location(s): Mumbai
Keyskills: C Data Management Data Collection MS Office Clinical Trials ICH-GCP Data Quality QC Excel Clinical Research Data Verification Clinical Data Management Quality Assurance
Doctors Without
Médecins Sans Frontières (MSF)/Doctors Without Borders 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 65 countries...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in
