Mission Specialized Activity Manager - Mumbai
- Doctors Without
- 4 - 5 years
- Mumbai
- 4 years ago
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Job Description
Vacancy: Mission Specialized Activity Manager (EndTb Trial)
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 exclusionfrom
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,andTelangana.
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 clinicaltrial 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. InIndia 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). Main Tasks & Responsibilities
Accountabilities :
Coordinating, monitoring and evaluating the proper functioning of a medical or paramedical activity at
mission level according to DWBI protocols, standards, and procedures, ensuring the implementation of
the activity (education and counseling sessions, defaultertracing,strengthening of support groups, linking
with social actors, community awareness activities, etc.)
Participating in the definition of strategies, protocols and activities of the mission and the projects for
his/her activity by assessing mission needs according to the changing medical needs and context
(including definition of log frame and budget) and developing tools (e.g. training materials, counseling
and education protocols, flyers, flipcharts, games)
Monitoring and evaluating the activity at mission level by defining indicators, following up tools and
designing contingency plans in collaboration with the Project Activity Managers (if required)
Functionally supervising the Project Activity Managers concerned and providing technical support
through regular project visits. Ensuring consistency and promotes cross-learning among the projects
DWBI Section/Context Specific Accountabilities :
Undergo training in the protocol, trial procedures (including Investigational productandTB lab),andGCP.
Support the Operational Research Coordinator and the central study coordinator in performing re-
training of Site staff as required.
Travel to trial clinic sites in Mumbai to verify patient, drugs and data managementis performedaccording
to locally established procedures and study protocol/SOPs/guidelines
Review Worksheets and other trial documents daily to ensure process consistency and adequacy of
processes and instruments used for data collection.
Review participants clinical files and perform Quality Assurance (QA) activities as detailed in the Site
Quality management plan.
Ensure data quality is of a high standard (i.e. performing source data verification in data entered in Open
Clinica).
Verify the Informed consent process is performed accurately.
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.Qualifications: Minimum Bachelor level qualification in Health Sciences,ora closelyrelated
field
Knowledge : Clinical trial regulation , ICH GCP Guidelines
Competencies : SOP preparations, Clinical Trial Monitoring, CAPA implementations
Experience:
Minimum of 4-5 years working in the health research field
A previous clinical trial or research experience (essential)
Site management/ Project management at Clinical trial site experience (essential).
Experience working on MDR-TB patient clinical documents (advantage) Verify that protocol deviation are properly documented and defined corrective/preventive actions
implemented.
Liaising with Mumbai based partners and service providers, including trial site.
In DWBI, liaising with support department heads to ensure adequate level of information and mobilize
necessary support to the trial implementation
Maintain the Investigator Site File and Central Investigator File content regularly.
Coordinate with TB and Clinical lab for sample pick up from the site and receiving results in time.Support
the external monitor during the monitoring visits.
Assist with additional tasks as agreed upon with study management. Benefits (Non-negotiable)
Monthly Gross Salary: INR 94,956/- 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
Duration 12 Months (Renewable)
Location: Mumbai
Expected Start Date: 1st November 2020 Contribute to advocacy activities within the DWBI endTB team and Mumbai project as a whole.
Prepare and submit regulatory and subject monitoring reports to the central Study Coordinator and the
laboratory monitoring report to the analytical manager
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 andaptitude
for humanitarian medical work.
Excellent computer skills (especially MS Office MS Word and MS Excel) & reporting skills.
Languages: English, Hindi & Marathi.To apply please email your CV and motivation letter with the subject Ref: Mission Specialized Activity Manager
To: ms**********i@br*****s.msf.org by 7th October 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: R&D
Role: R&D
Employement Type: Full time
Education
Under Graduation: Diploma in Any Specialization, B.Sc in Any Specialization, BHM in Any Specialization, Other Graduate, MBBS in Any Specialization, BHMS in Any SpecializationPost Graduation: PG Diploma in Any Specialization, Medical-MS/MD in Any Specialization, Radiology, Any Postgraduate 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
Location(s): Mumbai
Keyskills: ICH-GCP Guidelines Project Management ICH Data Quality Quality Assurance MS Office Education Counseling Health Research Clinical Trials Counselling
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...
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