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 Responsibilities
* Contribute to data management activities as a lead study data manager in support of Client's clinical studies
* Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
* Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
* Oversight of database lock activities and ultimate archiving of study data
* Collaborate 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 vendors
* Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
* Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
* Contribute 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 regulation
* Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
* Participate in the training of external vendors and site staff
* Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
* Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
* Support GCP inspection readiness
Qualifications
* BS/BA in scientific discipline,
* At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
* Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
* 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 Medidata Rave
* Experience using standardized medical terminology, including MedDRA and WHODrug
* Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
* Excellent written and oral communications 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
* NDA/MAA experience
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