Clinical Project Manager

Rio de Janeiro, Brazil
[Closing date: 31 July
2019]

 

Established in 2003 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.

After 15 years of sustained growth, DNDi has built a team of approximately 200 full-time employees working across nine offices (Geneva, Rio de Janeiro, Kinshasa, Nairobi, New Delhi, Kuala Lumpur, New York, Tokyo, and Cape Town).

The DNDi Latin America office was opened in 2004. With the primary aim to support regional R&D activities for Chagas disease and leishmaniasis, along with activities in hepatitis C, the Latin American office also undertakes advocacy and communications activities to increase neglected diseases awareness in the region. It also leads capacity building projects through multi-country research platforms.

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 registration, policy change, and product introduction. 

The team is based in DNDi’s headquarters office in Geneva and in our regional offices located in Africa, Asia, and South America.

 

Purpose of the position

The Clinical Project Manager is responsible for overall management of 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

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
  • Develop 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)
  • Draft the Request for Proposal (RFP) with the Procurement representative, for trial specify information
  • Attend the pre-selection or bid-defense meeting, and makes the final decision, jointly with their Direct Manager (on the vendor selection)
  • Review contractual documents and ensure that the clinical trial activities are performed according to these documents signed with the vendor and ether possible partners
  • 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
  • Be accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system
  • Ensure the appropriate safety management clinical trial teams as defined in the protocol, monitor plan and medical monitoring plan (if any) in compliance with the trial-specify safety management plan

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

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

  • Perform 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
  • Review and approve 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

Monitoring (set-up phase)

  • Designate an author for the Monitoring Plan, determine content contributors and designate reviewers of the Monitoring Plan, update and approve the Monitoring Plan as required
  • Ensure that the appropriate members (e.g. Monitors) have been trained before the first Monitoring visit occurs
  • Ensure 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 ensure that trial supplies are shipped in the appropriate conditions
  • Ensure 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

Trial management (conduct phase)

  • Provide support to the Direct Manager with regards to overall trial management and maintain adequate document control for all trial documents
  • Inform proactively the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget
  • Set-up regular meeting within the clinical trial team member and vendors
  • Perform and/or ensure vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced
  • Review various reports (Site Initiation Visit report, Site Monitoring Visit Report, documents related to monitoring, site close-out visit report, etc.)
  • Conduct co-monitoring visit during trial conduct
  • Ensure local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements
  • Ensuing DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP
  • Develop and coordinate any protocol amendment and coordinates the implementation of the trial specific documentation
  • File the trail specific documentation in the eTMF and ensure that the Trial Deviation Log is properly maintained and up-to date, and review the eTMF completeness on a regular basis
  • Coordinate distribution of IPs, labelling, track the IPs and ensure resupply and returns as well as destruction, while re-assessing needs an addressing potential quality incidents or complaints arising directly from the site
  • Document any non-implementation of a QD (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form
  • Report major and critical deviations to the QA unit, perform an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA
  • Develop CAPAs for the deviation, oversee implementation of all CAPAs, and report completion of all CAPA and final close-out in an updated Deviation Report Form

Trial management (reporting phase)

  • Provide clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team
  • Organize the Clinical Study Reports (CSR) Kick-Off meeting, coordinate the CSR development process, including its appendices, draft, review and approve the CSR, and files all the CSR reviews and approvals documentation on in the eTMF
  • Performing a full reconciliation with any externals stakeholders (vendors/consultants, etc…) prior to archiving
  • Archiving of the eTMF following closure of a trial and submission of the final trial report

 

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
  • Have 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 Drug Discovery/Development
  • 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 6 years’ relevant experience in which at least 4 years at Senior Officer level
  • 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 leishmaniasis and/or Chagas disease´s endemic countries highly desirable

Education

  • Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level

Other requirements

  • Fluency in English
  • Proficiency in Portuguese and Spanish
  • Very good knowledge of Microsoft Suite

 

Reporting line

  • S/he reports to the Senior Clinical Project Manager

 

Other information

  • Status: full time – permanent role

 

To apply

  • Deadline for application: Accepting applications until 31 July 2019
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants