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Clinical Quality Assurance Manager at Drugs for Neglected Diseases initiative (DNDi)

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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