Clinical Trial Pharmacist – projet endTB

  • Contract
  • France
  • Posted 3 weeks ago

Médecins Sans Frontières

Médecins Sans Frontières, an international medical humanitarian association created in 1971, provides medical assistance to populations whose lives are threatened: mainly in the event of armed conflicts, but also of epidemics, pandemics, natural disasters or exclusion from care. The French section of MSF is present in about thirty countries.

In the context of a replacement, we are looking for a Clinical Trial Pharmacist – endTB project (M/F)


EndTB is a project that aims to provide access to new treatments for patients with multi-drug resistant tuberculosis (MDR-TB). The project is conducted in partnership, with Partners in Health (PIH), Interactive Research and Development (IRD), Harvard Medical School (HMS), Institute of Tropical Medicine-Antwerp (ITM), Epicentre and University of California San Francisco (UCSF). The project is co-funded by Unitaid and some consortium partners.

The international multicenter randomized therapeutic clinical trial endTB-Q is currently on-going: 324 XDR-TB patients have been enrolled and it will end in Q4 2024.

This trial is currently conducted under the responsibility of MSF France as Sponsor in 8 sites in 5 countries: India (MSF project), Peru, Kazakhstan (PIH projects), Pakistan (IRD project) and Vietnam (UCSF project).

The project is coordinated by the Central Team, including about 15 people, distributed among various partners, some of whom are based in Paris.

Context and objectives

The Clinical Trial Pharmacist is part of the Central Team at Sponsor level, which includes Central Principal Investigators, Central Co-investigator, Project Manager, Clinical Trials Manager, Central Study Coordinators (in charge of following up on countries), Quality Assurance (QA) Officer, Data Manager, Biostatistician, Pharmacovigilance manager (PV) and Laboratory Experts.

In the endTB-Q study, the pharmaceutical activities responsibilities are distributed among several levels:

  • At country level, Site Principal Investigators delegate to the Site Pharmacists (a total of 8) the overseeing of the daily provision of drugs to the study participants in compliance with protocol, SOPs and regulatory requirements. The Internal Monitors (a total of 10) are also appointed to perform quality assurance activities at site level including pharmacy.
  • At Sponsor/Central level, the Clinical Trial Pharmacist is the primary contact point for the Site Pharmacists and the Internal Monitors to support pharmacy management in each country. The Clinical Trial Pharmacist works closely with the Central Study Coordinator of the country to ensure an effective communication flow, anticipate potential problems and find adequate solutions.

As Clinical Trial Pharmacist, you will bring an expertise in Investigational Medicinal Product (IMP) management, knowledge of the clinical trial regulations and drug safety and other relevant skills and experience to the implementation of an international multicenter randomized therapeutic trial. You will oversee and coordinate drug procurement, drug management and disposition. You will be responsible for ensuring compliance with the protocol, SOPs and applicable regulatory requirements (pertaining to IMP manufacturing, handling and storage, including ICH-Good Clinical Practice (ICH-GCP), Good Manufacturing Practice (GMP), Good Pharmacy Practice (GPP) and relevant national guidance) and support to pharmacy activities at site level.

Main responsibilities of the Clinical Trial Pharmacist – endTB project :

Under the supervision of the Clinical Trials Manager (from Sponsor level), you will work in close connection with the 3 Central Study Coordinators in charge of following up on countries, the Project Manager, the Quality Assurance Officer (QA) and MSF Logistique. At site level, you will work closely with the Sites Pharmacists and Internal Monitors from distinct partner organizations (MSF OCB, PIH, IRD, UCSF) and will have to ensure appropriate communication with the Central Study Coordination.


Support Site Pharmacists as focal point:

  • Ensure the site pharmacy activities are performed as per requirements by regular follow-up with relevant team.
  • Provide technical support to the sites, train Site Pharmacists and Internal Monitors remotely or during site visits.
  • Advise on site pharmacy human resource management to ensure adequation between site pharmacy staff and study activities.
  • Organize regular calls with the Site Pharmacists to maintain open communication and work together towards common goals (weekly to monthly depending on the sites).
  • Support the Site Pharmacists on pharmacy closure activities to ensure all the sites are closed as per timelines and requirements.

Follow-up of the drugs stock management:

  • Assist Site Pharmacists in ensuring optimal stock management of trial drugs (IMPs and non IMPs)
    • Monitor stocks on monthly basis and report to Central Team.
    • Identify and anticipate the need of donation/destruction and new orders if required.
    • Ensure Site Pharmacists are maintaining appropriate storage condition.
    • Review excursion reports and escalate to MSF Logistique as needed.
    • Troubleshoot problems that arise with storage.
  • Ensure the last drugs orders are delivered on time at Trials Sites
    • Coordinate the delivery process (placing orders through MSF Logistique and following up on orders until delivery).
    • Assist the Site Pharmacists in obtaining regulatory approval for drugs importation.
    • Facilitate custom clearance at Site level when required.
  • Ensure the unused drugs are disposed in timely manner:
    • Approve drugs disposition
    • Anticipate local regulatory requirements for drugs disposition
    • Support in finding local destruction vendors.

Quality Assurance of Pharmacy activities to help the Site Pharmacists to reach quality requirements:

  • Perform pharmacy monitoring to ensure proper pharmacy management as per protocol, SOPs and regulatory requirements, using risk-based approach:
    • Remote, monthly: review electronic ISF with Internal Monitors support, review and approve Internal Monitoring Pharmacy Reports.
    • On-site, occasionally: quality review of site pharmacy documents (e.g., stock, accountability logs, ISF), visit report redaction and findings escalation and follow-up.
  • Follow-up on pharmacy issues and Corrective and Preventive Actions (CAPA) definition, escalate to Central Team as needed.

Study documents:

  • Regularly update all pharmacy-related study documents, SOPs and forms (e.g. Pharmacy Manual, drug accountability logs, destruction SOP, etc.).
  • Coordinate with MSF Logistique, TB focal point pharmacist and regulatory affairs MSF pharmacist to gather and make available to sites all essential documents pertaining to and necessary to permit regulatory approval and importation of the IMPs (e.g. certificates of analysis, lot numbers, monetary values, GMP compliance certificates, etc.).
  • Support the Central Team in developing and updating the annual endTB Clinical Trial Reference Safety Information (RSI) and ensure that all IMPs information is accurate and up to date.
  • Maintain regular filing of the section Central Pharmacy of the electronic Trial Master File.


  • Assist Central Study Coordinator and Project Manager with the review of the endTB grant procurement strategy.
  • Perform forecast, budget revision and reporting on procurement in collaboration with the Project Manager.

This list of activities may be adjusted.



  • Registered Pharmacist with a pharmacy degree or higher – essential
  • Training in clinical trials – a strong asset


  • 3 years’ experience in drug procurement and management – essential
  • Experience in GCP-compliant multi-site clinical trials – essential
  • Experience working in or with resource-limited health systems – an asset

Knowledge and skills:

  • Knowledge of ICH-Good Clinical Practice (ICH-GCP), Good Manufacturing Practice (GMP), Good Pharmacy Practice (GPP)
  • Strong organization and planning skills
  • Ability to work with multicultural teams working remotely
  • Excellent interpersonal skills, team spirit and flexibility
  • Sense of initiative and cooperation, proactiveness in problem-solving
  • Proven skills to work with Office
  • Experience with QuanTB or strong willingness to learn
  • Flexibility for travelling in the trials’ countries

Additional skills:

  • Autonomy
  • Organization, rigor and respect of deadlines


  • Fluently spoken and written English (work mainly in English) – essential
  • Good level of French (occasional work in French with some interlocutors) – an asset, not mandatory

Status: Full time position, short-term contract until Dec 2024

Based in Paris, France. Jaurès metro station

Frequent travel to the sites (7 x 2 weeks travels currently anticipated in 2024)

Salary conditions: 46,50K€ gross annual salary over 13 months. 22 days RTT/year. Health insurance 100% covered by MSF. Restaurant vouchers with a face value of 9€ (60% paid by MSF). 50% of public transport pass paid.

Desired start date: early December 2023

How to apply

Please send your application (cover letter and CV in English, mentioning your availability date) until September 21, 2023 included


Only the candidates whose applications have been selected will be contacted.

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