RQM+
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts.
Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device
501 - 1000
Clinical Data Manager
August 12
🏡 Remote – Anywhere in California
RQM+
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts.
Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device
501 - 1000
Description
• Contributes to data management activities including eCRF development by leading cross-functional reviews of eCRF content. • Establishes Database building activities, including review of edit check specifications and performance of user acceptance testing. • Monitors data collection, remote and source data verification (SDV), coding, and cleaning by vendors through tracking of study metrics and targeted data reviews • Oversees of database lock activities and ultimate archiving of study data • Collaborates with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Product Safety; CROs, central and local laboratories, and other vendors. • Establishes cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews. • Reviews CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation. • Represents data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors. • Participates in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met. • Reviews clinical protocols/amendments, clinical study reports, statistical analysis plans, etc. • Supports GCP inspection readiness
Requirements
• BS/BA in scientific discipline, MS or equivalent preferred, with at least 3 years related experience in a medical device/diagnostic/software/pharmaceuticals/biologics/biotechnology company • Experience with global studies, utilizing an outsourced CRO model. • Experience in clinical MedTech and drug development through concept to post-approval • Education or work experience in a health-related field • Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems • Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH • Experience working with multiple EDC platforms. • Experience using standardized medical terminology, including MedDRA and WHODrug • Experience working with MS Office Suite (Excel, Word, and PowerPoint) and familiarity with MS Project • Excellent written and oral communication skills • Highly motivated and flexible, with excellent organizational and time management skills • Ability to work independently and as part of a multi-disciplinary team • Understanding of ICH GCP as well as general knowledge of industry practices and standards • Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 and applicable ISO and CFR regulations.
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