Purpose of the position

The Clinical Project Manager is responsible for overall management and coordination of at most two clinical trials, s/he is responsible to provide support and documentation of 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. S/he ensures smooth running of clinical trials, according to DNDi’s SOPs, Good Clinical Practices, other ICH Guidelines and in compliance with overall local, regional and international regulatory obligations associated with study/ies conduct. S/he acts a team coordinator for the clinical team trials. 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
• The implementation of the clinical trial according to the agreed timelines, quality, and budget
• That the trial is inspection ready

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/coordinate the timely development of 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
• 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 ether DSMB members
• In coordination with the Medical Manager, define the DSMB operating procedure (detailed in the DSMB charter), ensure proper DSMB development, signature, file approval as defined in the 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 define the requirements that the potential trial site must have for conducting a clinical trial
• Review and approve the site pre-study visit report and evaluate, based on the pre-study visit report, the feasibility of running the trial at the site visited and agree on the site selection in collaboration with the Direct Manager

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
• Forecast 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
• Ensure DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP
• Develop and coordinate any protocol amendment, and coordinate 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. 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
• Organise 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 in the eTMF
• Perform a full reconciliation with any external stakeholders (vendors, consultants, etc.) prior to archiving
• Archive the eTMF following closure of a trial and submission of the final trial report

Additional/ specific/ projects responsibilities

• Drive clinical trials teams in a matrix environment
• Achieve database lock of complex clinical trials
• Coordinate the preparation and compilation of complex Clinical Study Report and appendices
• Oversee and keep track of submissions of essential documents/ reports to local IRBs/ HAs, and notify the end of the trial
• Contribute to the review and writing of publications

Reporting line

• S/he reports to the Head of Visceral Leishmaniasis Project
• Close working relationship with the Head of Regional Clinical Operations (EA), relevant members of the DNDi East Africa regional office, and DNDi global disease teams

Interactions

• Work in coordination with the Visceral Leishmaniasis team, based in Geneva, and in the regional offices, as well as with other transversal R&D units (Medical Affairs, Pharmaceutical Development, Translational Sciences)
• Interact regularly with the partners involved in the programme, service providers/ vendors, external stakeholders
• Member of ARO Senior Management team
• Supervise Visceral Leishmaniasis Project Coordinators and Clinical Research Associates at ARO

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

• Excellent knowledge of Drug Discovery/Development
• Excellent knowledge of Clinical Research/Development
• Excellent knowledge of Regulatory (GCP, GLP, and GMP)
• Excellent knowledge of Disease/academia knowledge
• Excellent 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

Education

• Medical degree (MBChB) graduate
• Postgraduate/ masters degree in relevant field a plus

Other requirements

• Travel up to 50%