GARDP Clinical Trial Manager – Neonatal Sepsis

Geneva, Switzerland
[Closing date: 2 March 2018]
                                                                 

    

Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org).

The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavoring to ensure sustainable access. Initiated and incubated through close collaboration between WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships for encouraging research and development of new antimicrobial agents and diagnostics.

GARDP’s mission is to work in partnership with the public and private sectors, to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which inadequate treatment exists.

GARDP is currently hosted and facilitated by DNDi, which provides the scientific environment, necessary personnel, and infrastructure to ensure an effective start-up phase.

 

Overall purpose

The main purpose of the role is to coordinate trial related activities for the Neonatal sepsis programme, through ensuring the respect of the rights, the safety and the protection of the persons participating in any clinical trial, the adherence to applicable regulations and guidelines, and of the clinical trial protocol. The CTM will also assure the accuracy, completeness, consistency with the source data collected and the compliance with the objectives, the planning, the timelines, and the clinical trial budget

 

Specific job responsibilities

Project management

  • Planning, set-up, and follow-up of the clinical trials
  • Follow-up of the clinical trials progress: monitor milestones, compliance with the recording deadlines, presentation meeting of the clinical trial progress to the project team
  • Selection and management of subcontractors
  • Management of clinical budgets and invoices
  • Development of clinical trials tools
  • Interaction with external boards (e.g. Advisory Panel)
  • Provide progress reports to Project Leader on individual projects including budget updates on a regular basis

Trial design and set-up

  • Coordinate the development and secure approval of the clinical trials documents (Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form)
  • Management of the clinical trial set-up and team
    • Supervise all administrative steps (e.g. submission to competent authorities and ethics committees…)
    • Support investigators’ selection and organization of Investigators’ Meeting
    • Supervise trial logistics coordination (with Clinical Research Assistant – CRA)
  • Liaison with the CRAs/subcontractors for appropriate trial site set-up
  • Supervise maintenance of the clinical trial documentation

Regulatory compliance

  • Ensure clinical trial compliance with GCP and other applicable regulatory requirements as applicable
  • Supervise preparation of regulatory documentation
  • Prepare and review clinical SOPs and other standard documents required for clinical trials
  • Contribute to the set up and review of GARDP systems related to clinical operations as appropriated

Clinical trial follow-up and reporting

  • Follow-up of the trial allocated budget
  • Liaison with the CRAs/subcontractors for appropriate site monitoring
  • Management of possible protocol amendments and other follow-up issues during clinical trials
  • Management of the Serious Adverse Events and other safety issues during the clinical trial
  • Follow-up of the subcontracted data management and statistical activities
  • Notification of the end of the clinical trial
  • Coordination of the development of the Clinical Study Report and its appendices
  • Supervise maintenance of the clinical trial documentation
  • Provide progress reports to Head of STI Programme and senior management members on individual projects including budget updates, on a regular basis
  • Assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

 

Job requirements

Skills and attributes

  • Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
  • Strong communication skills in multicultural, multi-lingual environments
  • Strong ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Strong analytical skills
  • Strong ability to provide high level support in project/programme delivery
  • Strong ability to manage medium/large projects with budget management
  • Has autonomy for taking actions and decisions
  • Strong ability to interact with external stakeholders
  • Lead and motivate a small team for optimum performance, supervising junior staff

R&D technical skills

  • Excellent knowledge of the applicable regulation for clinical trials and in Good Clinical Practices
  • Knowledge of the laboratory requirements for clinical trials

Experience

  • Minimum 6 years clinical trial management experience
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of managing external partners, e.g. CRO
  • Experience of conducting paediatric clinical trials

Other requirements

  • Fluency in English
  • Position based in Geneva with frequent travels to Asia, Africa, and Latin America

 

Reporting line

  • S/he reports to the Paediatric/Neonatal Sepsis Project Leader

 

Other information

  • Status: full time – permanent role  

 

To apply

  • Please submit your application using the online form
  • Deadline for application: Accepting applications until 2 March 2018
  • Only shortlisted candidates will be contacted.