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  • Posted: Apr 8, 2021
    Deadline: Not specified
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  • Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organizations - Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur - as well as an internati...
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    Clinical Project Manager - Mycetoma

    Purpose of the position

    The Clinical Project Manager is responsible for overall management of the clinical trial, S/he will play an important role in the development of new drugs and treatments for neglected diseases. S/he act as a team coordinator for the clinical team trials. S/he will be responsible for the management in the coordination, support and documentation of the clinical trial phases of the product development, guaranteeing:

    The respect of rights, safety and protection of the persons participating in the clinical trial.
    The respect of the applicable regulations and recommendations, and of the Clinical Trial Protocol
    Accuracy, completeness and consistency of the data collected.
    Implementing the clinical trial according to the agreed timelines, quality and budget.

    Specific Job Responsibilities

    1. Meetings and Documentation/Contract Management (Set-Up Phase)
      1. In the set-up phase, set-up the kick-off internal meetings and regular trial team meetings.
      2. Supports timely development of key documentation (Protocol Synopsis, ICF, protocol, Trial Risk Management Plan, Medical Monitoring Plan, Trial Monitoring plan, Data Management Plan and Statistical Analysis Plan.
      3. Drafts the Request for Proposal (RFP) with the Procurement representative, for trial specify information.
      4. Attends the pre-selection or bid-defense meeting, and makes the final decision, jointly with their Direct Manager (on the vendor selection)
      5. Reviews contractual documents and ensures that the clinical trial activities are performed according to these documents signed with the vendor and ether possible partners.
      6. Set-up of the trial specific and electronic Trial Master File (eTMF) at the beginning of the trial and organizes the eTMF in accordance with the TMF Table of Content.
      7. Is accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system.
    2. DSMB: Data Safety Monitoring Board (Set-Up Phase)
      1. Evaluates the need for a DSMB (with the validation of the Direct Manager, documents the decision.
      2. Defines the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in the SOP.
      3. Ensures submissions to Ethics Committees (EC)/Institutional Review Boards (IRB) or Regulatory Authorities (RA) of DSMB related information if required as per local regulations (DSMB charter)
    3. Site Selection (Set-Up Phase)
      1. Performs the evaluation of the potential site (investigator’s qualifications, trial site staff qualifications, facilities, resources) as per DNDi SOPs and defines the requirements that the potential trial site must have for conducting a clinical trial,
      2. Reviews and approves the site Pre-Study Visit report and evaluates, based on the Pre-Study Visit report, the feasibility of running the trial at the site visited and agrees, in collaboration with the Direct Manager on the site selection.
    4. Monitoring (Set-Up Phase)
      1. Designates an author for the Monitoring Plan, determines content contributors and designates reviewers of the Monitoring Plan and updates and approves the Monitoring Plan as required
      2. Ensures that the appropriate members (e.g. Monitors) have been trained before the first Monitoring visit occurs.
      3. Ensures collaborative support from Data Management, PV and other functions as required, to develop the trial specify documentation needed for the trial, and inform the Procurement function, when applicable.
    5. Investigational Product Orders (Set-Up Phase)
      1. Forecasts the needs for investigational Products (IPs) in collaboration with Pharmaceutical Development unit, budget purchases, order trial supplies, and ensures that trial supplies are shipped in the appropriate conditions.
      2. Ensures that trial supplies have been received and stored at site level in the appropriate conditions & stock management and that trial equipment maintenance is done at site level in a timely manner, according to manufacturer recommendations.
    6. Trial Management (Conduct Phase):
      1. Provides support to the Direct Manager with regards to overall trial management and maintain adequate document control for all trial documents,
      2. Inform proactively the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget,
      3. Set-up regular meeting within the clinical Trial team member and vendors
      4. Perform and/or ensure vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced,
      5. Reviews various reports (Site Initiation Visit report, Site Monitoring Visit Report, documents related to monitoring, site close-out visit report etc)
      6. Conducts co-monitoring visit during trial conduct.
      7. Ensures local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements.
      8. Ensuing DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP.
      9. Develop and coordinate any protocol amendment and coordinates the implementation of the trial specific documentation.
      10. Files the trail specific documentation in the eTMF and ensures that the Trial Deviation Log is properly maintained and up-to date, and reviews the eTMF completeness on a regular basis,
      11. Coordinates distribution of IPs, labelling, tracks the IPs and ensures resupply and returns as well as destruction, while re-assessing needs an addressing potential quality incidents or complaints arising directly from the site.
      12. Documents any non-implementation of a QD (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form.
      13. Reports Major and Critical deviations to the QA unit, performs an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA.
    7. Trial Management (Reporting Phase):
      1. Provides clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team, 
      2. Organizes the Clinical Study Reports (CSR) Kick-Off meeting, coordinates the CSR development process, including its appendices, drafts, reviews and approves the CSR, and files all the CSR reviews and approvals documentation on in the eTMF.
      3. Performing a full reconciliation with any external stakeholders (vendors/consultants, etc...) prior to archiving,
      4. Archiving of the eTMF following closure of a trial and submission of the final trial report.

    Reporting line

    1. S/He reports to the Senior Clinical Project Manager
    2.  Close working relationship with the Head of Regional Clinical Operations, relevant members of the DNDi African regional office, Nairobi and DNDi global disease teams.
    3. Supervises Mycetoma and ANTICOV Project Coordinators and Clinical Research Associates at ARO 

    Job Requirements

    Experience

    1. Minimum 6 years' relevant experience in which at least 4 years at Senior Officer level
    2. Proven ability to work effectively in a team environment and matrix structure.
    3. Experience of working in public and private sector is highly desirable.

    Education

    1. Medical degree (MBChB) graduate.
    2. Postgraduate/masters degree in relevant field a plus

    Method of Application

    Interested and qualified? Go to Drugs for Neglected Diseases initiative (DNDi) on dndi.org to apply

    Note: Never pay for any training, certificate, assessment, or testing to the recruiter.

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