Jobs at Drugs for Neglected Diseases initiative (DNDi)

Purpose of the position

To support the Finance team in the effective and efficient delivery of financial support to the DNDi Africa Regional Office (DNDi ARO) operations, projects and clinical trials and the implementation of the global financial management strategy, with a strong emphasis on donor financial management, financial planning, budgeting and partner management activities.

Specific Job Responsibilities

Donor Financial Management (50% of the role) – provide effective financial management support throughout the life cycle of donor funded projects from proposal development to project close out and audits:

• In collaboration with the R&D, External Relations and Finance teams, develop financial proposals in compliance with donors’ requirements.
• Review donor contracts before signature to clearly understand financial management requirements and disseminate these to the relevant teams (R&D and non-R&D) including external partners involved in the grants.
• Provide excellent financial monitoring and advisory support to the DNDi program teams and partners to appropriately manage the grant funding over its life cycle.
• Prepare intermediate and final financial reports for donor submissions in collaboration with R&D and External Relations teams, ensuring compliance with the grant’s legal, procurement and financial requirements.
• Enhance global grants management capacity by enabling the sharing of best practices via training, guidelines and tools development, and process improvements.

Partnership management (30% of the role) - ensure DNDi project partners implement Good Financial Practice (GFP) principles in the management of project funds.

• Reviewing budgets submitted by DNDI partners to ensure all activity costs are captured and are in line with the action plan.
• Conduct visits to partners including organizing pre-contract assessments to assess the partners’ capacity to support effective project financial management.
• Implement the audit tool kit which will provide periodic reports to help identify areas of improvements related to partner financial management and the required technical assistance.
• Ensure partner financial reports are submitted on time and are in line with contract terms and GFP principles.
• Provide trainings and technical assistance to partners either on a one to one basis and/or in workshops.

Budget management (20% of the role) – provide financial planning and budget follow-up support to ensure operations/projects are implemented within the approved annual budgets and in compliance with both DNDi and donor financial requirements.

• Participate in internal meetings to understand the budget, income, timelines, and key challenges of the projects / disease and support budget owners develop their rolling budgets.
• Conduct periodic budget follow up with budget owners , to ensure the respective budget owners understand and control their budgets, and are accountable for their expenditure against the budget.
• Support the implementation of the Finance KPIs dashboard to facilitate decision-making and arbitrations by senior management.
• Support Project Leads measure the financial impact of projects risks and document the cost of mitigation measures.
• Coach the project teams on the budget process, good budgeting and budget analysis practices and contribute to regular training of project leaders and budget holders on finance matters.

Job Requirements

Skills and Attributes

• Solid business partnering expertise with experience working with senior leaders and negotiating with both internal and external stakeholders in a global matrix, multi-cultural environment.
• Strong ability to manage a complex and diverse workload and work well under pressure to meet tight deadlines.
• Well organized and structured with very clear and systematic thinking demonstrating analytical skills and problem-solving competencies.
• Good project management skills and proven ability to work collaboratively across functions to deliver on complex, multifaceted projects.
• Fluency in English. Proficiency in French is an added advantage.

Behaviours

• Professional competence
• Care of relationships
• Leading by example

Experience

• Minimum 12 years' relevant experience with at least 4 years in a similar senior finance role.
• Prior grant budget development, compliance, and financial reporting experience, with a good understanding of major institutional donor requirements including budgeting, eligibility issues, compliance management, and reporting.
• Proven experience in partner financial management and oversight in resource-limited settings.
• Working experience with accounting software e.g., Navision
• Very good knowledge of Microsoft Suite especially MS Excel and MS PowerPoint
• Proven ability to work effectively in a team environment and matrix structure
• Experience working in a clinical research environment and leading/supervision of a finance team is a plus.

Education

• Master's degree or equivalent
• CPA (K) or equivalent

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Purpose of the position

The Senior Clinical Research Associate is responsible for the set-up and follow-up of a range of clinical trials / observational studies in sites according to DNDi’s SOPs, applicable regulation and Good Clinical Practice, other ICH Guidelines and in compliance with overall local, regional and international regulatory obligations associated with the study/ies conducted. Where applicable, to ensure the safety of the patients participating in clinical trials and get reliable clinical data. (Clinical trial set-up and clinical trial monitoring). The incumbent acts as lead CRA, managing a team of CRAs who are monitoring the studies.

Specific Job Responsibilities

• Initiate preliminary contact with the site investigator
• Responsible to set-up and coordinate the pre-study visits, write the Pre-study visit report and conduct the site Initiation visit at the trial site with the support of the CRAs
• Writes the Pre-study visit report
• Conducts the site Initiation visit at the trial site
• Ensures that the trial site safely and properly conducts the clinical trials.
• Reviews the ICF (the master and/or local language version as appropriate and any updates)
• Conducts the Site Monitoring Visits at the trial sites
• Verifies the validity, accuracy, consistency and quality of the data in Case Report Forms (CRFs) or data collection forms (e.g., data/forms sent to DNDi Pharmacovigilance) against source documentation.
• Checks compliance of the clinical trial conduct according to the protocol, GCP and the applicable regulations.
• Reviews the investigator Site File (ISF) for completeness
• Ensures appropriate test article storage, expiry date, dispensing, and accountability, if applicable.
• Verifies proper filing of any Safety expedited reporting or safety /clinical periodic reporting to Independent Ethics Committees (IECs)/institutional Review Board (IRB) / Regulatory Authorities (RAs)/other institutions (if applicable),
• Reviews safety reporting requirements and compliance (including tracking)
• Conduct the site close-out visit in the clinical sites
• Submits the site close-out visit reports to the Clinical project Manager for review and approval
• Contribute to and review the Monitoring Plan,
• Perform activities as per the Monitoring Plan
• Responsible for the initial set-up of the ISF
• Regularly reviews the ISF during the monitoring visits to ensure it is up to date and that the essential documents for the centers overseed are appropriately recorded and filled in the investigator site file
• Provides support to the Head Diseases/TS with regards to local/regional safety regulatory intelligence,
• Provides in a timely manner necessary information to the PV function to develop the SMP. This includes providing necessary information to ensure SMP readiness prior to study initiation in each country, to the CPM and PV function, including on all local regulations and guidance’s (together, if necessary, with translation into English and interpretation). This includes seeking validation of interpretation of implementation modalities with regulatory bodies (RAs/ECs/other bodies), if necessary.
• Provides support to the CPM to track compliance with local safety reporting requirements in their region/country; this includes tracking submission dates and documenting submission (collecting proof of submission/notification) and sharing these documents with PV function and CPM (or delegate) for filing in TMF.
• Ensures the appropriate safety management at trial sites as defined in the protocol, monitoring plan and medical monitoring plan (if any) in compliance with the trial-specify Safety Management Plan. This includes source data verification, support to sites in completing trial-specify documents sent to PV and CRF data/queries, consistency check between documents sent to PV and CRF and request for correction, as necessary
• Verifies that any deviations are properly documented,
• Alerts the Clinical Project Manager in a timely manner in case of any issue and documents any findings in the monitoring reports
• During monitoring visits: Check that equipment is properly used and maintained, check that stock of consumables has not reach the alert threshold, check that expired consumables are put in quarantine or destroyed according to CPM authorization
• For IP returns, organizes shipment to the appropriate recipient,
• For IP destroyed on site, requests a certificate of destruction

Reporting line

• Senior Clinical Research Associate reports to Senior Project Manager

Job Requirements

Skills and Attributes

• Very good knowledge of Drug Discovery/Development.
• Very good knowledge of Clinical Research/Development.
• Very good knowledge of Regulatory (GCP, GLP and GMP).
• Very good knowledge of Disease/academia knowledge.
• 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.
• Very good communication skills in multicultural, multi-lingual environments.
• Ability to work effectively as part of a multicultural team.
• Well organized and structured.
• Very good analytical skills.
• Ability to contribute to the project delivery under minimum supervision.
• Ability to manage small projects if delegated by upper levels with supervision.
• Ability to supervise an Intern or Apprentice.

Experience

• Minimum 6 years’ relevant experience in which at least 3 years at Officer level or equivalent
• Proven ability to work effectively in a team environment and matrix structure.
• Experience of working in public and private sector is highly desirable.

Education

• Graduate or post graduate degree in relevant field.