Senior Clinical Data Team Lead
il y a 2 semaines
The Sr. CDM will lead and contribute to data management activities in support of Client's studies across all stages of clinical drug development.Summary of Key ResponsibilitiesContribute to data management activities as a lead study data manager in support of Client's clinical studiesLead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testingMonitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviewsOversight of database lock activities and ultimate archiving of study dataCollaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendorsEstablish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviewsReview CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentationContribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulationRepresent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendorsParticipate in the training of external vendors and site staffParticipate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are metReview clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.Support GCP inspection readinessQualificationsBS/BA in scientific discipline,At least 7 years related experience in a pharmaceutical/biologics/biotechnology companyExperience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferredExpert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management SystemsKnowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASHExperience working with Medidata RaveExperience using standardized medical terminology, including MedDRA and WHODrugExperience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS ProjectExcellent written and oral communications skillsHighly motivated and flexible, with excellent organizational and time management skillsAbility to work independently and as part of a multi-disciplinary teamUnderstanding of ICH GCP as well as general knowledge of industry practices and standardsKnowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11NDA/MAA experienceIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
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Clinical Data Standards Manager
il y a 1 semaine
Brussels, Belgique SolCur Temps pleinSummary of the Clinical Data Standards ManagerActs as the functional expert in clinical data standards required by regulatory authorities and industry groups such as CDISC.Supports Clinical Data Managers, Data Management Leads, and the wider Clinical Trial Team to ensure clinical data is complete, accurate, consistent, and ready for regulatory...
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Senior Director, Clinical Biometrics
il y a 2 jours
Brussels, Belgique WhatJobs Temps pleinSenior Director, Clinical Biometrics & Analytics Join to apply for the Senior Director, Clinical Biometrics & Analytics role at Chiesi Group Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its...
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Clinical Trial Lead
il y a 1 semaine
Brussels, Belgique Hobson Prior Temps pleinHobson Prior are currently looking for a Clinical Trial Lead to join a fantastic pharmaceutical organisation on a permanent basis located in Belgium. Our client is focused on generating a healthier society. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this position, you...
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Clinical Data Specialist
il y a 2 semaines
Brussels, Belgique R&D Partners Temps pleinJoin a growing Clinical Data Management team as a Clinical Data Specialist and help shape the future of data integrity in clinical research!R&D Partners is seeking a Clinical Data Specialist to join a leading organization who are continuously growing their Clinical Data Management function.Please note that to be considered for this role you must have the...
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Clinical Data Specialist
il y a 2 semaines
Brussels, Belgique R&D Partners Temps pleinJoin a growing Clinical Data Management team as a Clinical Data Specialist and help shape the future of data integrity in clinical research! R&D Partners is seeking a Clinical Data Specialist to join a leading organization who are continuously growing their Clinical Data Management function. Please note that to be considered for this role you must have the...
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Director Clinical Operations Development Lead
il y a 2 jours
Brussels, Belgique CT19 Temps pleinDirector Clinical Operations Development Lead- Rare DiseaseLocation- Candidates must live in BelgiumRemote role and occasional travel to HQ in Europe may be requiredAbout the CompanyWe are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their...
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Director Clinical Operations Development Lead
il y a 2 jours
Brussels, Belgique CT19 Temps pleinDirector Clinical Operations Development Lead- Rare DiseaseLocation- Candidates must live in BelgiumRemote role and occasional travel to HQ in Europe may be requiredAbout the CompanyWe are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their...
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(Junior) Clinical Data Capture Designer
il y a 1 semaine
Brussels, Belgique Oxford Global Resources Temps pleinJob Description As part of the ongoing expansion of one of our client's Global Clinical Operations Department, they are currently looking for a Junior Clinical Data Capture Designer/eCRF Designer to join their Data Management (DM) team in Brussels. In this role, you will work closely with Clinical Data Managers and senior Study Designers. While Data Managers...
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(Junior) Clinical Data Capture Designer
il y a 1 semaine
Brussels, Belgique Oxford Global Resources Temps pleinJob Description As part of the ongoing expansion of one of our client's Global Clinical Operations Department, they are currently looking for a Junior Clinical Data Capture Designer/eCRF Designer to join their Data Management (DM) team in Brussels. In this role, you will work closely with Clinical Data Managers and senior Study Designers. While Data Managers...
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Senior Clinical Research Associate
il y a 2 semaines
Brussels, Belgique Planet Pharma Temps pleinPlanet Pharma are currently partnered with a global clinical research organisation and we are actively seeking a Senior CRA to join the business on a permanent basis, fully remotely in Belgium.Key Responsibilities:Monitor clinical trial sites to ensure studies are conducted according to protocol, Good Clinical Practice (GCP), and regulatory...
