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Clinical Data Manager
2 months ago
RQM+ is the largest global MedTech CRO, offering consulting, clinical trial, lab and reimbursement services across the entire product lifecycle. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.
Clinical Data Manager
The Clinical Data Manager develops and implements data-oriented systems to meet the needs of the organization. Duties include developing systems, procedures, and policies for data management for the Clinical Trials team and assisting colleagues in performing data-related tasks.
Key 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 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
Key Requirements
- BS/BA in a scientific discipline, MS or equivalent with 3-5 years’ 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
