Doctors Without Borders India Medecins Sans Frontieres MSF
Clinical Research Operations Manager for our EndTB Trial
Research Analysts, Research Associate, Research Assistant
Mumbai Maharashtra
Application Email : msfocb-mumbai@brussels.msf.org

Job Type

Full Time

Closing Date

Aug 01 2021

Description

Vacancy: Clinical Research Operations Manager for our EndTB Trial
(Operational Research Coordinator)

Doctors without Borders India

Main Tasks & Responsibilities :

Main Purpose:

The 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.

Accountabilities:

• 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.
• Responsible for the EndTB trial budget and participate in the monthly forecast exercise.

Specific Accountabilities:

With the support of the Mumbai project management team, the endTB Clinical Research Operations
Manager will:

• 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.
• Support 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 (ICF) etc
• Responsible for recruitment of site staff together with the HR department.
• Ensure that all study staff is trained according to the protocol, operating procedures and GCP.
• 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 pharmacy.
• 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 Sites.
• 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.
• Provide 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.
• Ensure 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.

Doctors Without 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.

Doctor without Borders India (DWBI) runs projects in the states of Bihar, Chhattisgarh, Delhi, Jammu and Kashmir, Jharkhand, Maharashtra, Manipur.

Doctors Without Borders India (DWBI) and the endTB project

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.

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).

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 skills
• Excellent people management skills with proven experience
• Ability to organize and prioritize workload & taking initiative
• 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.
• Excellent reporting skills.

Qualifications:

Minimum 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 monitor).
• Experience with Trial Site set-up and Study implementation is preferred. Clinical Research Coordinator Certification (CRCC) is an asset.
• Comprehensive 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.

Languages: Good Knowledge of English & Local Languages (Hindi, Marathi)

Benefits (Non-negotiable)

Monthly Gross 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 week

Duration: 24 Months (Renewable)

Location: Mumbai

Expected Start Date: 1st September 2021

To apply please email your CV and motivation letter with the subject Ref: CROM (EndTB) to: msfocb-mumbai@brussels.msf.org by 1st August 2021 23:00 pm.

ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW. www.msfindia.in
Job Email id: msfocb-mumbai@brussels.msf.org