Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five publicly-funded research organizations – Malaysian Ministry of Health, Kenya Medical Research Institute, Indian Council of Medical Research, Oswaldo Cruz Foundation Brazil, and the Institut Pasteur – as well as an international humanitarian organization, Médecins Sans Frontières. The UNICEF/UNDP/World Bank/WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) is a permanent observer. With a robust portfolio, DNDi aims to develop new, improved, and field-relevant drugs for neglected diseases, including leishmaniasis, human African trypanosomiasis (sleeping sickness), Chagas disease, malaria, filarial diseases, paediatric HIV, mycetoma, and hepatitis C that afflict the poorest populations of the world.
Purpose of the position
The Clinical Quality Assurance (CQA) Manager supports the Clinical Quality Management System to ensure:
- Compliance of R&D staff with regulatory and company Ethical and Good Clinical Practice requirements
- Patient safety and data integrity are respected
- Risks are identified, investigated, corrected, and communicated to the CQA Leader for escalation to Senior Management if necessary
- The clinical staff, trials, and sites are inspection-ready at all times
Specific job responsibilities
Quality documents (QDs)
- Support the implementation of a practical, user-friendly, compliant system for the management of the DNDi Clinical QDs
- Support the overall life-cycle management of Clinical QDs (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement)
- Support development of QDs for the CQA function
- Review all other Clinical QDs for compliance with regulations, company policies, other QDs
- Ensure availability of current QDs to all DNDi staff on an electronic platform
- Provide controlled copies to external parties
- Support gap analyses of processes
- Support process improvement and QD optimization activities
Training
- Support company approach for staff training by providing or coordinating training (eg. GCP, QA, Risk Management, QDs)
- Support maintenance of system to ensure availability of clinical staff training records (CVs, JDs, training logs & records)
Clinical trial support & optimisation
- Replace CQA Leader or Senior CQA Manager at Extended Disease Team meetings when needed
- Be an ad hoc member of Trial teams, attend meetings as needed, and review meeting minutes
- Attend other meetings as required, in line with need/internal procedures
- Act as GCP expert/consultant and provide expertise, support, and/or respond to questions from R&D staff on GCP/QA questions
- Provide support with interpretation of regulatory guidelines
- Support CQA Leader input to QA section of Clinical Development Plans, where applicable
- Identify potential risks in trial management activities and communicate these to the trial responsible and CQA Leader
Audits/quality control
- Provide input to Audit Plan from discussions/feedback with Trial teams
- Support management of out-sourced audit activities, including liaison with auditee and DNDi contact, review of draft audit reports
- Liaise with auditee for the completion of a Corrective/Preventive Action Plan (CAPA plan) and oversee follow-up and timely close-out of CAPA
- Feed information into the tracking tool to be able to provide trends on audits and audit findings
- Perform quality control reviews of key trial documents (protocols, Informed Consent forms, Clinical Study Reports, Investigator Brochures, and others if requested)
Inspections (or external audits)
- Support inspection preparation activities and may be called upon to remain with inspector(s) during inspection
- Provide support to develop and feedback on the inspection CAPA
- Feed information into the tracking tool for trends on audits and audit findings
Risk management
- Follow and maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
- Support clinical staff to implement the deviation process
- Support Risk Management Plans for clinical activities
- Support risk management and risk mitigation activities
- Interact with the Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues
- Ensure escalation to CQA Leader of major or critical quality issues or risks
- Participate in regular CQA meetings to discuss QA/GCP issues and align/harmonize approach
Additional/specific/projects responsibilities
- Support organization of Global Clinical Meeting
- Participate to and provide information and support for Annual Clinical Quality Review Meeting
- Provide GCP guidance or quality advice to other DNDi functions (Fundraising, Procurement, Legal)
Reporting line
- S/he reports to the Clinical Quality Assurance Leader based in Geneva
Job requirements
Skills and attributes
- Strong 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
- Strong communication skills in multicultural, multi-lingual environments
- Strong ability to work effectively as part of a multicultural team
- Well organized and structured
- Strong analytical skills
- Strong ability to provide high level support in project/programme delivery
- Strong ability to manage medium/large projects with budget management
- Strategic thinking and leadership abilities
- Strong management, negotiation, and advocacy skills
- Have autonomy for taking actions and decisions
- Strong ability to interact with external stakeholders
- Lead and motivate a small team for optimum performance, supervising junior staff
R&D technical skills
- Good knowledge of drug discovery/development
- Very strong knowledge of clinical research/development
- Very strong knowledge of ethical principles, pertinent regulatory requirements and Good Clinical Practice (GCP), and company policies and procedures
- Good knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
- Strong technical writing skills (procedures, protocols, and reports)
Experience
- Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level
- Proven ability to work effectively in a team environment and matrix structure
Education
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
Other requirements
- Fluency in English
- Proficiency in local languages desirable
- Very good knowledge of Microsoft Suite
Other information
- Status: Full time
- Some travel will be required
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