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Clinical Trial Manager (CTM)

Background

Drugs for Neglected Disease initiative (DNDi), a not-for-profit organization, has as its main goal to provide 6 to 8 new treatments for Leishmaniasis, Sleeping sickness (HAT), Chagas disease and Malaria until 2014; and also establish a solid portfolio of projects in R&D to develop treatments that meet patient’s needs. By using R&D networks based on South-South and North-South cooperation, DNDi aims to provide medical innovations to patients. DNDi also has two other goals related to capacity building and advocacy:
·    Use and strengthen existing capacity in disease-endemic countries through the implementation of projects.
·    Promote awareness of public opinion on the need to develop new drugs for neglected diseases and encourage governments to take greater responsibility.
At regional level, the DNDi Latin American is going through an important period of growth both in terms of the projects under development and in terms of building a sustainable institution of R&D. The main priorities are reflected in the regional plan of action as:
·    Building relevant Operations: delivering results and excellence in programming;
·    Sustaining an ambitious development in Latin America: institutional and territorial.

Purpose of the Position

To help sustain the growth of its activities in the region, DNDi, through its regional office in Rio de Janeiro, is recruiting a full time Clinical Trial Manager (CTM). The CTM will play an important role in support of the development of new drugs and treatments for neglected diseases. S/he will be involved in the coordination and support of projects throughout all stages of the development process, with particular focus on the clinical phases. As a CTM s/he will report to the Head of the Chagas Clinical Program in the DNDi R&D team, Dr Isabela Ribeiro, and directly oversee the use of DNDi resources for given projects. The CTM will have an active participation within DNDi in issues and discussions not restricted to Chagas Disease clinical trials.

Main Responsibilities

As CTM, the employee will specifically be responsible for the management of the Azoles clinical study/ies in the Chagas Disease portfolio, and will perform, when needed, other activities related to these projects:

·    Development of the clinical study protocol, other study specific documents and related budget with the help of the relevant experts
·    Conduct feasibility assessments and selection of study sites
·    Identification of the human, infra-structure and logistical resources needs
·    Participation to the selection of CROs if appropriate, with the Head of Program
·    Management of any coordination activities whether outsourced or not
·    Report to the Head of Program on the progress of the study  
·    For regional projects, to liaise with the local Regulatory authorities as part of a global strategy agreed with the Head of Program
·    Play a full role in the R&D team

Specific Responsibilities

1. Ensure regulatory compliance for projects
·    To be familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies
·    To ensure projects follow GCP and regulatory compliance and keep appropriate documentation
·    To participate in preparing regulatory documentation
·    To prepare and review clinical SOPs and other standard documents required for clinical trials
·    Contribute to set up and to review of DNDi systems related to clinical operations as appropriate

2. Manage and develop project reporting systems
·    To collect data and information to enable Head of Program and the Clinical Development Director to make effective and cost-efficient use of DNDi resources
·    To interact with study site teams on a regular basis to ensure that projects meet their milestones
·    To provide logistical support and tracking for all trial materials with the trial monitors and site investigators
·    To liaise with the project consultants and collaborators within the project network, notably the Chagas Platform
·    To write a monthly project update

3. Enable review of projects
·    To provide progress reports to Head of Program on a regular basis
·    To assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

4. Personal
·    To develop and maintain the skills required for delivery of all aspects of clinical trials
·    To maintain an awareness of all developments in Chagas disease that relate to drug development and disease control
·    To be aware of developments in clinical development and the regulatory environment, and report these to DNDi

Qualifications

·    S/he will have high level scientific qualifications (M.Sc., MD or PhD) in a relevant discipline with a proven record of organizational skills.
·    At least 4 years of proven experience in clinical R&D
·    English and Spanish are mandatory
·    Portuguese is highly appreciated

Key Competences

S/he will maintain confidentiality in performing the duties of CTM and also demonstrate to: be honest and trustworthy, possess cultural awareness and sensitivity, demonstrate sound work ethics and engagement with DNDi’s principles and objectives.

S/he will have high level interpersonal skills and an ability to interact in international research collaborations. Verbal and written communications skills, time management and flexibility complete the skills required for this position.

Working term and Conditions

The CTM will be based in Rio de Janeiro and will therefore attend all team and coordination meetings on a regular basis as well as be prepared for work related travelling.

Workplace:         DNDi Latin America’s office in Jardim Botânico – Rio de Janeiro – Brazil
Time employment:    100% (full-time position)
Mobility:        Frequent sites visits and representations trips (~20% of the time)
Type of contract:     Indeterminate Contract (with a 3 month probation period)
Starting Date:        January 2012


Motivated and qualified candidates are highly encouraged to send their CV along with a personal statement to Este endereço de e-mail está protegido contra spambots. Você deve habilitar o JavaScript para visualizá-lo. until December 15th 2011. Only short-listed candidates will be contacted.