Senior Clinical Project Manager

Rio de Janeiro, Brazil
[Closing date: 1 October 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

S/he is responsible for the management and coordination of several clinical trial(s), S/he supports and documents the clinical trial phases of the product development, s/he is responsible for the trial budget, through delegation of budget accountability from the Head of the Disease/Project Leaders. S/he ensures the smooth running of clinical trials, according to DNDi SOPs, Good Clinical Practice, other ICH Guidelines and in compliance with overall local, regional, and international regulatory obligations associated with the study/ies conducted. S/he manages the clinical trial team, and directly supervises the Clinical Project Manager(s) or in smaller trials directly the (Sr) CRAs. S/he guarantees:

  • 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
  • S/he ensures that the trial is inspection ready
  • Participation to the development strategy and ensure implementation of strategy at the level of clinical trial

 

Specific job responsibilities

Site selection (set-up phase)

  • Perform the evaluation of the potential site(s) (investigator’s qualifications, trial site staff qualifications, facilities, resources) as per DNDi SOPs and define the requirements that the potential trial site must have for conducting a clinical trial
  • Supervise the logistics aspects (e.g. site rehabilitation, site equipment supplies and shipment)
  • Recommend the site selection to the Head of Disease/Project Leader, who validates the choice
  • Manage the clinical trial team, and directly supervise the CPM or in smaller trials directly the (Sr) CRAs
  • Participate in the Clinical Dev. Plan team

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

  • In the set-up phase, set up the trial kick-off internal meeting and regular trial team meetings
  • Preparation/participation to investigators’ meeting
  • Responsible for trial specific documentation (Protocol, ICF and Protocol synopsis) with support from the trial team
  • Responsible for third party selection and agreement together with the procurement representative
  • Oversee or set-up themselves of the trial specific TMF at the beginning of the trial and organize the TMF in accordance with the TMF SOP
  • Coordinate the submission to competent authorities and Ethics Committees, as applicable
  • Coordinate the trial budget preparation
  • Register the study in public web-based study registry (e.g. ClinicalTrial.gov)
  • Coordinate the set-up and organization of the DSMB and or Safety review committee per DNDi SOP
  • Is accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system

Monitoring (set-up phase)

  • Designate an author for the Monitoring Plan, determine content contributors, and designate reviewers of the Monitoring Plan, and update and approve the Monitoring Plan as required
  • Ensure that the appropriate members (e.g. CRA’s) 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
  • Coordinate labeling according to regulations in the country of the study
  • 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 and closeout)

  • Responsible for the overall trial management and maintaining adequate document control for all trial documents, monitor milestones, compliance and budget, and present the clinical trial progress to applicable team
  • Provide updates for donor reports
  • Perform and/or ensure vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced
  • Ensure local/regional tracking of compliance (directly or by delegation to CRA’s) with local safety reporting requirements
  • Ensure DSMB procedures are followed ensuring the distribution and follow-up of their recommendations
  • Develop and coordinate any protocol amendment and coordinate the implementation of the trial specific documentation, and document submission to competent authorities and Ethics Committees during the clinical trial, as applicable
  • Responsible (with support from trial team) for the filing of the trial specific documentation in the TMF and ensures that the Trial Deviation Log is properly maintained and up-to date, and reviews the TMF completeness on a regular basis
  • Coordinate 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
  • Document any non-implementation of a Quality Document (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 and develop or review the CAPA, in addition to informing the direct manager, perform an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA and oversees the implementation of all CAPAs
  • Coordination of data base lock(s) and release of results (e.g. data cleaning, medical review)
  • Oversee the quality systems, have in place processes to guarantee data integrity
  • Responsible for the close out of the trial clinical trial (site closure visits, ensure all data is cleaned, database locked, …) per DNDi SOPs
  • Ensure 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-specify safety management plan

Trial management (reporting phase)

  • Organize the Clinical Study Reports (CSR) kick-off meeting, coordinate the CSR development process, including its appendices, draft, review, and approve the CSR, and file all the CSR reviews and approvals documentation on in the eTMF
  • Perform a full reconciliation with any external stakeholders (vendors/consultants, etc…) prior to archiving
  • Perform TMF reconciliation and archiving of the TMF following closure of a trial and submission of the final trial report

Contribution to R&D activities

  • Participate in strategic discussion of the CDP including regulatory
  • Participate in the preparation and review of the document for the NDA/CTA application (e.g. module 2.7.3, 2.7.4)
  • Support Fundraising team, as applicable (e.g. coordinate work package/grant, donor report)
  • Review scientific publication, and participate in publication release and results presentation in international congress, as applicable
  • Participate/present in DNDi or expert management meeting (e.g. RDLT, SAC)
  • Participate in management partner relationship
  • Review scientific publication, and participate in publication release and results presentation in international congress, as applicable

 

Reporting line

  • S/he reports to the Senior Clinical Project Manager and Medical Manager

 

Job requirements

Skills and attributes

  • Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
  • Very strong communication skills in multicultural, multi-lingual environments
  • Very strong ability to work effectively as part of a multicultural team
  • Very well organized and structured
  • Very strong analytical skills
  • Very strong ability to lead project delivery
  • Very strong ability to manage large size projects with budget management
  • Strong strategic thinking and leadership abilities
  • Very strong management, negotiation, and advocacy skills
  • Very strong ability to exercise high degree of independence to support programme delivery and explore new areas of activities
  • Very strong ability to interact with internal and external stakeholders
  • Lead and motivate a team for optimum performance, supervising junior staff

R&D technical skills

  • Very strong knowledge of drug discovery/development
  • Excellent knowledge of clinical research/development
  • Very strong knowledge of regulatory (GCP, and GMP)
  • Very strong technical writing skills (procedures, protocols, and reports)

Experience

  • Over 8 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 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

 

Other information

  • Status: full time – permanent role  

 

To apply

  • Deadline for application: Accepting applications until 1 October 2019
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants