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Clinical Research Manager
Clinical Research Manager The Global Antibiotic Research and Development Partnership (GARDP) is a not - for - profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavoring to ensure sustainable access. Initiated and incubated through close c ollaboration between WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public - private partnerships for encouraging research and development o f new antimicrobial agents and diagnostics. GRDP’smissionistoworkinpartnershipwiththepublicandprivatesectors,todevelopanddelivernewtreatmentsfor bacterial infections where drug resistance is present or emerging, or for which inadequat e treatment exists. Purpose of the position The GARDP paediatric program aims to lead the development of antibiotics, both old and new, providing an evidence base for their use in children and babies with serious bacterial infections (SBIs), as the currently av ailable standard of care in many countries is increasingly becoming less effective due to antimicrobial resistance. Other long - term objectives include the development of formulations that are adapted for use in children, as well as collaborations with WHO and other relevant stakeholders to ensure that the R&D innovation of new treatments encompasses a solid strategy for stewardship, and affordable and sustainable access. Contribution The Clinical Research Manager for Paediatric program plays a leading role in the development and conduct of Paediatric Investigation plans for existing antibiotics or those that are in late stage clinical development or recently registered for use in adults. S/he will also contribute and lead where appropriate clinical research work streams to support project development plans and access strategies. S/he will be involved in the supervision, development and regulatory review of clinical trial projects in children of all ages in high and low and middle - income country settings. S/he will ensure the smooth running of Clinical Trials, according to Good Clinical Practice and other ICH Guidelines. S/he will maintain and generate documentation pertaining to the management of the trial and will manage partners and Clinical Research Organiz ations to insure the above goals are obtained. As a Clinical Research Manager s/he will be expected to maintain frequent interaction with investigators, partners, and project team. Tasks and Responsibilities: Project Management • Planning, set - up and follow - up of research projects • Follow - up of the clinical trials progress: monitor milestones, compliance with the recording deadlines, presentation meeting of the clinical trial progress to the project team • Selection and management of subcontractors • Management clinical budgets and invoices • Development of clinical trials tools • Provide progress reports to Project Leader on individual projects including budget updates on a regular basis Trial design and set - up • Planning, set - up and follow - u p of all aspects of clinical trials and other aspects • Coordinate the development and secure approval of the clinical trials documents (Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form) • Management of the clinical trial set - up and team: o Supervise all administrative steps (e.g. submission to Competent Authorities and Ethics Committees) o Support investigators' selection and organization of Investigators' Meeting o Supervise trial logistics coo rdination (with Clinical Research Assistant - CRA) • Liaison with the CRAs/subcontractors for appropriate trial site set - up • Supervise maintenance of the clinical trial documentation Regulatory compliance • Ensure clinical trial compliance with GCP and other ap plicable regulatory requirements as applicable • Supervise preparation of regulatory documentation • Prepare and review clinical SOPs and other standard documents required for clinical trials • Contribute to the set up and review of GARDP systems related to clin ical operations as appropriated Clinical trial follow - up and reporting • Follow - up of the trial allocated budget • Liaison with the CRAs/subcontractors for appropriate site monitoring • Management of possible protocol amendments and other follow - up issues during clinical trials • Management of the Serious Adverse Events and other safety issues during the clinical trial • Follow - up of the subcontracted data management and statistical activities • Notification of the end of the clinical trial • Coordination of the developm ent of the Clinical Study Report and its appendices • Supervise maintenance of the clinical trial documentation Clinical trial documentation • Finalize the development and secure approval of the clinical trial documents: Clinical Trial Protocol, Statistical Analysis Plan, Data Management Plan, Informed Consent Documents, Case Report Form, etc. • Coordination of the clinical trial documentation Clinical development plan & clinical trial protocol • Participate in the Clinical Development Plan Team • Ensure that safety and quality standards are integrated in planning • Ensure regulatory compliance in planning Oversight of the clinical trial follow - up and clinical trial report • If required set - up DSMB (Data Safety Monitoring Board) with input from projec t lead, ensuring proper DSMB operating procedure including recommendations distributions as defined in the SOP directly • Coordination, directly or by oversight of the CTM of the clinical trial logistics (sending, return, destruction of the study supplies) • M anagement, directly or through CTM, of possible Clinical Trial Protocol Amendments, other follow - up issues and possible administrative steps (e.g. submissions to Competent Authorities and Ethics Committees) during the clinical trial • Oversight of the mainte nance of the clinical trial documentation Project Review Assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews Interactions • Works within the Paediatric/Neonatal Sepsis Pro gram team, and interacts with external partners, DNDi CMC, QA and PV teams • He/she has a representational role through the promotion of programs and maintain productive relationships by projecting the image of a credible partner • S/he works closely with the teams including Communications and Fundraising, Finance & Administration, Legal, Business Development, and Regional Offices R&D Technical Skills • Excellent knowledge of Clinical Research/Drug Development process • Excellent knowledge of GCP and clinical re gulatory requirements • Knowledge of other Regulatory requirements (GLP and GMP) • Excellent technical writing skills (procedures, protocols and reports) • Knowledge of Infectious disease/academic knowledge desirable Experience • Minimum 6 years in senior role conducting all aspects of clinical research • Proven ability to work effectively in a team environment and matrix structure • Experience of working in public and private sector is highly desirable • Experience of conducting paediat ric clinical trials desirable Education • Life Sciences, or Paramedical, Pharmacist • Advanced post - graduate degree (PhD or MSc) or equivalent in experience to reach Master level in Life Science / Healthcare discipline would be an advantage Other Requireme nts • Excellent English mother tongue writing skills • Excellent knowledge of Microsoft Suite • Position based in Geneva with frequent travels to Asia, Africa, and Latin America To apply • Please submit your application using the online form • Deadline for applica tion: Accepting applications until April 12th 2019 • Only shortlisted candidates will be contacted


Website https://www.gardp.org/