France: CLINICAL TRIAL MANAGER (M/F)

Mission :

EndTB is a consortium of 3 partners: Partners In Health, Interactive Research and Development and Médecins Sans Frontières, and is funded by Unitaid.

endTB aims to find shorter, less toxic and more effective treatments for ‘multidrug-resistant TB’ (MDR-TB) through: access to new drugs, a clinical trial, advocacy at national and global levels.

The clinical trial manager will support the execution of a Phase III, open-label, randomized clinical trial to evaluate the safety, tolerability, and efficacy of novel drug regimens for patients with drug-resistant tuberculosis (DR-TB). The study will be implemented in at least 7 international centers, across 6 countries. The trial is under the supervision of 2 co-principal investigators, from HMS (Harvard Medical School) and from MSF France.

The study manager will lead all aspects of study planning across institutions (PIH, MSF, Harvard Medical School, Epicentre, and Institute of Tropical Medicine), including procurement, logistics, clinical operations, data management, laboratory, quality control/assurance, regulatory, legal, and financial. He/she will develop (and maintain) a central trial project management plan, with milestones and projections, informed by site implementation plans. He/she is accountable for Good Clinical Practices (GCP) compliance.

Main responsibilities:

Part of the medical department and under the supervision of the principal investigators:

You will manage the organization of the multicenter research trial, and in particular

· Study set up

· development and maintenance of study documents, including (but not limited to) protocol, standard operating procedures, manual of procedures;

· registration, regulatory approvals for protocol and associated study documents centrally, (and with study coordinators, across sites), with strict version control;

· multi-center research aspects of internal and external audits, monitoring;

· execution of activities as delegated to consortium members

· central study coordinators

You will be responsible for the good implementation of the trial through the followings:

· Systems analysis, identifying areas needing improvement and suggesting working solutions;

· Performing site visits (including initiation and close-out),

· Communicating study progress to central team

· Organizing and chairing management meetings in person or virtually

· Actively tracking progress to ensure completion according to specified timelines, budget and quality standards

· Training and supporting central team members and study coordinators on study protocol and serving as point of contact for managing/answering questions relating to trial procedures;

· Maintaining a good working knowledge of applicable institutional guidelines for proper research conduct and local regulations;

· Maintenance of the central trial master file;

Profile

• PharmD or MD

• BS or Master degree in clinical research.

• At least 5 years in multi-site clinical research management required

Languages:

• french and fluency in english mandatory

• spanish and russian (professional) would be an asset

Desired Qualifications

• Pack Office and project management tools skills

Additional Qualifications

• Work experience in resource-limited settings

• Ability to work in a multi-cultural professional environment and with teams based in different locations

• Autonomy, work under minimal supervision

• Knowledge of international regulations/guidance governing clinical research;

• Flexible for regular travel to study sites and meetings with central team (up to 20% of time)

Status

Short term contract 18 months duration

Full time. Based in Paris

Salary conditions: Gross Annual salary 47.8K€. Comprehensive benefits provided.

Starting date: as soon as possible an

Please submit all applications (CV and cover letter) only by email to:

http://www.msf.fr/recrutement/salariat

Deadline for applications: 7 of February

Only short-listed candidates will be contacted