RQM+ is hiring a
Clinical Data Manager

Summary

Join the Clinical Data Manager team at RQM+, where you'll develop and implement data-oriented systems, collaborate with internal and external partners, and contribute to data management activities. As a key member of our organization, you'll have opportunities for ongoing learning and development, and enjoy an industry-leading compensation package.

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

Responsibilities

• 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 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