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 .
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-defence 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.
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.
• 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.
• 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.
Qualifications
• 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.
