Summary
Date Posted: Wednesday, June 29, 2022 , Base Salary: Not Disclosed

JOB DETAILS:
Job description
The Senior Clinical Project and Medical Manager is responsible for the management and coordination of several clinical trial(s). The position supports and documents the clinical trial phases of the product development and is responsible for the trial budget, through delegation of budget accountability from the Head of the Disease/Project Leaders. The Senior Clinical Project and Medical Manager 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. The Senior Clinical Project and Medical Manager manages the clinical trial team, and directly supervises the Clinical Project Manager(s) or in smaller trials directly the (Sr) CRAs. The Senior CPM and Medical Manager 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.
• Ensures that the trial is inspection ready
• Participation to the development strategy and ensure implementation of strategy at the level of clinical trial.

The Senior Clinical Project and Medical Manager supports the provision of appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the trial team, medical advisors/Clinical Project Leaders from Clinical Trial Units, investigators and KOLs under the guidance of the Head of Disease/Head of Translational Science while following the standards and policies provided by the Medical Affairs Director. Is the medical reference in the assigned clinical trial team. Is responsible for participants’ safety oversight within the assigned trial.

Specific job responsibilities
Project leader responsivities
• Oversee the execution of the approved project plans, identification of critical success factors and indicators for project evaluation
• Accountable for the project’s deliverables
• Lead the project team
• Coordinate with functional leadership on project activities
• Lead the development and/or implementation of the project integrated clinical development plan
• Support the CPM’s or the CRAs (when no CPM in place) to ensure that the investigators implement rigorous and quality clinical studies that meet ICH standards
• Ensures efficient and cost-effective use of DNDi resources
• Organize regular project reviews and team (core and extended) meetings, inviting other DNDi members as appropriate
• Produce and coordinate materials and presentations for the SAC and DAC project reviews
• Review the progress reports at interim and formal management reviews
• Advise on appropriate external experts to enhance the review process as required

Clinical trial leader responsibilities
Site selection (set-up phase)
• Performs the evaluation of the potential site(s) (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,
• Supervise the logistics aspects (e.g. site rehabilitation, site equipment supplies and shipment)
• Recommends the site selection to the Head of Disease/Project Leader, who validates the choice
• Manages the clinical trial team, and directly supervises the CPM or in smaller trials directly the (Sr) CRAs
• Participates 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 organizes the TMF in accordance with the TMF SOP,
• Coordinates the submission to Competent Authorities and Ethics Committees, as applicable
• Coordinates the trial budget preparation
• Register the study in public web-based study registry (e.g. ClinicalTrial.gov)
• Coordinate the setup 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)
• 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. CRA’s) 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
• Coordinating labelling 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 & 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)
• 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
• Coordinating labelling 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 & stock management and that trial equipment maintenance is done at site level in a timely manner, according to manufacturer recommendations

Trial management (reporting phase)
• Organizes the Clinical Study Reports (CSR) Kick-Off meeting, coordinates the CSR development process, including its appendices, drafts, reviews and approves the CSR, and files all the CSR reviews and approvals documentation on in the eTMF
• Performing a full reconciliation with any external stakeholders (vendors/consultants, etc...) prior to archiving,
• Performs TMF reconciliation and archiving of the TMF following closure of a trial and submission of the final trial report.

Contribution to R&D activities
• Participation in strategic discussion of the CDP including regulatory
• Participation in preparing 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 participation in publication release and results presentation in international congress, as applicable
• Participation/presentation in DNDi or expert management meeting (e.g. RDLT, SAC)
• Participation in management partner relationship
• Review scientific publication, and participation in publication release and results presentation in international congress, as applicable

Medical management
Trial document support and contributions
• Write/contribute/review/QC/validate trial related documents: clinical protocols, written subject information, trial disclosure form, Case report form, trial plans (e.g.: medical monitoring plan, safety management plan, trial risk management plan, monitoring plan), trial reports, material for training and meetings (such as investigators and DSMB Meetings).
• Review relevant clinical documents (include but not limited to: ICF, patient diary, CRF completion guidance, vendor specifications, specific guidelines as applicable) and make sure they are medically sound.
• Review other clinical documents including but not limited to IB, DSUR, PSUR.
• Collaborate with the trial statistician(s) to develop SAP.

Medical monitoring of trials
• Responsible for overall supervision/execution of medical validation/review of trial data, including writing or supervision of trial related documents (e.g.: medical monitoring plan, guidelines, etc…).
• The Senior Clinical Project and Medical Manager performs the Medical Monitoring according to the Medical review specification
• The Senior Clinical Project and Medical Manager contributes to 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.
• As per the PV safety management plan, responsible for SAE review and reporting for the assigned clinical trials.
• Collaboration with PV in assessing signals of risk and the overall risk-benefit of the drugs in the regimen

DSMB and other scientific boards related activities
• Responsible for DSMB organization and content and is key contact person for DSMB, and prepare related material (e.g. charter, presentations, agenda and minutes).
• Working with the team to identify members of Steering Committee, DSMB and any other boards and finalize the relevant charter with the Trial Team.
• Co-responsible for protocol training together with CPM during investigator meeting or site initiation visits, answer questions related to medical issues the trial.
• Facilitate medical safety data submission/review/discussion with regulatory health authority and/ DSMB/business partners

Nairobi-Regional Management team
• Is part of the regional management team, and takes part of the development of the regional strategy under the supervision of the regional executive director
• Is part of the preparation and implementation of the regional Action Plan.
• Participates to the preparation of the annual budget, as well as their regular revisions.
• Identifies risks potentially impacting projects and/or DNDi activities as well discuss them to address and suggest mitigation strategies with the other MT members.
• Participates in the monthly management team meetings in the Region as well as ensure a fluid regional internal communication

The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. This job description may be subject to review.

Reporting line
• This role reports to the Head of Global Clinical Operations

Job requirements
Skills and attributes
• 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)
• 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 program 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

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


Work Hours: 8

Experience in Months: 96

Level of Education: Bachelor Degree

Job application procedure
Method of Application
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