Vacancy: Clinical Research
Operations Manager for our EndTB Trial
Doctors without Borders India
Tasks & Responsibilities :
endTB Clinical Research Operations Manager will bring clinical
research experience and be responsible for managing both the endTB
and endTB-Q clinical trials at the participating sites (Mumbai and
Pune) in India. Based in Mumbai or Pune with frequent travels
between the two cities, he/she will manage and supervise the Site
coordinator in Pune and the Site coordinator based in Mumbai.
He/she will be accountable for the overall conduction of the
studies in India. The Clinical Research Operations Manager will
liaise with regulatory authorities and partners at national level,
as well as State and local level before and after the Studies
approval as representative of the endTB project in India (under
the supervision of the Project Management Team). He/She will take
care of obtaining (and maintain) Ethic and Regulatory authorities’
approval working in close collaboration with the Sponsor, the
Country Principal Investigator (PI) and the two Site PIs.
• Ensure the
protection of the rights, safety, and welfare of all study
participants and safety of study staff.
• In collaboration
with the Coordinating PI as well as the Site PIs and under the
guidance of the Sponsor team, ensure studies start-up activities,
budget development, staff recruitment, are performed in a timely
and accurate manner.
• Oversee subject recruitment and
study enrollment goals.
• Make sure the study is planned,
set up, conducted, documented and reported according to the
protocol, effective standard operating procedures (SOPs), GCP, and
applicable international and national regulations.
Support the Internal Monitors and the two Site Coordinators to
ensure that site trial staff adheres to the study procedures,
verification procedures, audits and inspections procedures.
Collaborate and support the Coordinating PI and the Site PIs in
preparation and timely submission of reportable adverse events to
the MSF Pharmacovigilance Unit, central research team, local
authorities, and relevant ethics committees.
for the EndTB trial budget and participate in the monthly forecast
the support of the Mumbai project management team, the endTB
Clinical Research Operations
Be responsible to evaluate site capacity (material and staff) and
identify efforts to be deployed to reach site initiation.
Provide support and manage the endTB Site Coordinator in Mumbai
and Pune for the conduct of the clinical trial.
the Sponsor, the Coordinating PI, the Site PIs and the Site
Coordinators in preparation of documents to obtain study
amendments approval from all local relevant authorities, including
drug license importation. Monitor study progress and prepare
progress reports for EC/RA as required.
• Review and
ensure conformity with local requirements and GCP requirements all
trial documents relevant to the site, including the study
protocol, the patient information leaflet, informed consent form
• Responsible for recruitment of site staff
together with the HR department.
• Ensure that all study
staff is trained according to the protocol, operating procedures
• Ensure with the Site and Trial pharmacists that
study drugs will be available at dispensing site according to
trial schedule, are stored according to trial standards and that
drug accountability is organized on recruitment site and at the
• Ensure that quality assurances are in place
according to the requirements set by the Analytical project
manager from ITM (Antwerp, Belgium) for TB laboratories and with
other laboratories for clinical lab tests.
• Ensure the
Investigator Site Files (ISF) are properly maintained at the
• Ensure with the Site PIs that notifiable events
are reported on time to the MSF Pharmacovigilance unit and to the
relevant ethics committee(s) and regulatory authorities.
Ensure data is recorded, handled, stored and reported accurately
and promptly and confidentiality is maintained.
patient data (collected in eCRF, SAEs and other notifiable events)
and pre-screening/screening logs to central research team and
external monitor or any audit, when required.
study visits are organized within the Clinical trial required
timeframe for all study participants.
• Facilitate the
visit of the external monitor at the Sites and ensure corrective
actions and preventive actions indicated by the external monitor
are timely implemented.
• To be the focal point for any
communications related to the EndTB trials in consultation with
the Project Management team.
• Interact with the logistic
team so that clinical trial requirements are defined and met both
in terms of space and processes.
Borders India (DWBI)/ 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. DWBI offers assistance
to people in need and irrespective of race, religion, gender or
political affiliation. Ensure that MSF's charter, policies and
Doctors Without Borders India 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. 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.
without Borders India (DWBI) runs projects in the states of Bihar,
Chhattisgarh, Delhi, Jammu and Kashmir, Jharkhand, Maharashtra,
Doctors Without Borders India (DWBI) and the
Doctors Without Borders India, 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 world’s 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.
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).
We are looking for a
Senior Management profile within the field of Clinical Research;
• Must have distinctive communication, time
management, strategic thinking, negotiation and problem-solving
• Excellent people management skills with proven
• Ability to organize and prioritize workload &
• Excellent collaboration skills and
demonstrated ability to work across multiple organizations in
pursuit a common goal and to engage credibly with senior
counterparts across multiple sectors
• 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.
• Demonstrates flexibility in taking
up tasks outside of regular job responsibilities as required and
aptitude for humanitarian medical work.
Masters level qualification in Health Sciences/ Pharmacy/
Medicine, PHD would be an added advantage. Experience:
Interventional Clinical Trial experience as Clinical Research
Operations Manager (or equivalent, i.e. study coordinator or study
• Experience with Trial Site set-up and Study
implementation is preferred. Clinical Research Coordinator
Certification (CRCC) is an asset.
knowledge and understanding of Indian clinical research
regulations and GCP
• Thorough understanding of human
subject’s data confidentiality
• Previous experience in
Tuberculosis field desirable
• Experience with electronic
medical records and/or data capturing systems is desired
Project or people management experience is essential.
Good Knowledge of English & Local Languages (Hindi, Marathi)
Salary: INR 119,429 and Secondary Benefits as per policies:
13th Month Salary/ Festival Bonus
• 18 Annual Leaves
12 Casual Leaves
• Other compassionate leaves
Medical Reimbursement including dependents
• 48 hours work
Duration: 24 Months (Renewable)
Expected Start Date: 1st September 2021
apply please email your CV and motivation letter with the subject
Ref: CROM (EndTB) to: email@example.com by 1st August
2021 23:00 pm.
ONLY SHORT-LISTED CANDIDATES WILL BE
CONTACTED AND INVITED FOR INTERVIEW. www.msfindia.in
Email id: firstname.lastname@example.org