Clinical Project Manager, Visceral Leishmaniasis

Geneva, Switzerland
[Closing date: 4 August
2019]

 

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).

DNDi‘s neglected tropical disease (NTD) Initiative is dedicated to clinical development and access for the following NTD areas: Human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, and mycetoma. The NTD Initiative is responsible for developing overall and disease-specific strategy, conducting and reporting on research, supporting fundraising efforts, and managing budgets – from phase 1b/proof of concept studies right through to registration, policy change, and product introduction. 

The Visceral Leishmaniasis (VL) Clinical Programme is based in DNDi’s headquarters office in Geneva and in our regional offices located in Africa, Asia, and South America. The aim of the programme is to improve the currently existing treatments, and the long-term goal is to develop new oral treatments for VL that are safe, highly efficacious in both children and adults and adapted to field conditions.

 

Purpose of the position

The Clinical Project Manager is responsible for overall management of clinical trials, S/he will play an important role in the development of new drugs and treatments for VL. 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

Meetings and documentation / contract management (set-up phase)

  • In the set-up phase, set up the kick-off internal meetings and regular trial team meetings
  • Develops on time key documentation (Protocol Synopsis, ICF, protocol, Trial Risk Management Plan, Medical Monitoring Plan, Trial Monitoring plan, Data Management Plan, Statistical Analysis Plan, etc… (non-exhaustive list)
  • Drafts the Request for Proposal (RFP) with the Procurement representative, for trial specific services
  • Attends the pre-selection or bid-defense meeting, and makes the final decision on the vendor selection, jointly with the Direct Manager
  • Reviews contractual documents and ensures that the clinical trial activities are performed according to these documents signed with the vendor and other possible partners
  • Sets up 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
  • Is accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system.
  • Ensures the appropriate safety management clinical trial teams as defined in the protocol, monitors plan, and medical monitoring plan (if any) in compliance with the trial-specific safety management plan
  • Registers the study in public web-based study registry (e.g. ClinicalTrial.gov)

DSMB: Data Safety Monitoring Board (set-up phase)

  • Evaluates the need or not for a DSMB (with the validation of the Direct Manager and the Medical Director, and documents the decision, and proposes the DSMB chairperson and other DSMB members
  • Defines the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in this SOP
  • 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)

Site selection (set-up phase)

  • Participates in 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
  • Recommends the site selection to the Head of VL Programme, who validates the choice

Monitoring (set-up phase)

  • 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
  • Ensures that the appropriate members (e.g. Monitors) have been trained before the first Monitoring visit occurs
  • 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

Investigational product orders (set-up phase)

  • 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
  • Ensures IP labelling is done according to regulations in the country of the study
  • Ensures that trial supplies have been received and stored at site level in the appropriate conditions and stock management, and that trial equipment maintenance is done at site level in a timely manner, according to manufacturer recommendations

Trial management (conduct phase)

  • Responsible for the overall trial management and maintains adequate document control for all trial documents, monitors milestones, compliance, and budget, and presents the clinical trial progress to applicable team
  • Informs proactively the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget
  • Sets up regular meeting within the clinical trial team member and vendors
  • Performs and/or ensures vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced
  • Reviews various reports (Site Initiation Visit report, Site Monitoring Visit Report, documents related to monitoring, site close-out visit report etc)
  • Conducts co-monitoring visit during trial conduct
  • Ensures local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements
  • Ensures DSMB procedures are followed, including recommendations, distributions, and DSMB documentation filing as defined in the relevant SOP
  • Develops and coordinates any protocol amendment and coordinates the implementation of the trial specific documentation
  • 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
  • Coordinates distribution of IPs, labelling, tracks the IPs, and ensures resupply and returns as well as destruction, while re-assessing needs and addressing potential quality incidents or complaints arising directly from the site
  • Documents any non-implementation of a quality document (QD) (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form
  • 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
  • Develops CAPAs for the deviation, oversees implementation of all CAPAs, and reports completion of all CAPA and final close-out in an updated Deviation Report Form
  • Ensures the appropriate safety management by clinical trial teams as defined in the protocol, monitoring plan, and medical monitoring plan (if any) in compliance with the trial specific safety management plan

Trial management (reporting phase)

  • Provides clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team, 
  • Organizes the Clinical Study Reports (CSR) Kick-Off meeting, coordinates the CSR development process, including its appendices, drafts, reviews and obtaining final approval for the CSR (as per SOP), and files all the CSR reviews and approvals documentation in the eTMF
  • Performs a full reconciliation with any external stakeholders (vendors/consultants, etc…) prior to archiving
  • Archiving of the eTMF following closure of a trial and submission of the final trial report

Additional / specific / projects responsibilities

  • Support the Head of VL Programme in
    • Organizing meetings with health authorities, partners and stakeholders, including logistics, list of participants, meeting agenda, preparation of documentation, presentations, as required

 

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
  • Strategic thinking and leadership abilities
  • Strong management, negotiation, and advocacy skills
  • 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

  • Very strong knowledge of Clinical Research/Development
  • Very strong knowledge of Regulatory (GCP, GLP and GMP)
  • Very strong knowledge of disease/academia knowledge
  • Very strong technical writing skills (procedures, protocols, and reports)

Experience

  • Minimum 8 years’ relevant experience in which at least 6 years in senior role
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable
  • Experience of working in VL endemic countries (South Asia, Eastern Africa, and Latin America) is highly desirable

Education

  • Advanced postgraduate degree or graduate degree with equivalent in experience to reach Master level
  • Medical Doctor degree is highly desirable

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Very good knowledge of Microsoft Suite
  • Travel up to 25%

 

Reporting line

  • S/he reports to Head of VL Programme

 

Other information

  • Status: full time – permanent role

 

To apply

  • Please submit your application using the online form
  • Deadline for application: Accepting applications until 4 August 2019
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants