Job Description
Responsibilities:
- Lead data management activities as a program-level lead data manager in support of Alnylam 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, internal data reviews and vendor key performance indicators.
- Oversight of database lock activities and ultimate archiving of study data.
- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, 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, conduct data reviews and oversee data review of team members.
- Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation.
- Collaborate with Statistical Programming to oversee SDTM validation efforts, performing review of validation reports, SDTM Reviewer Guides and define.xml files, and coordinating feedback to CRO while driving internal decision-making and overseeing issues to resolution.
- Lead development and implementation of departmental workflows and infrastructure strategy & development (such as SOPs, work instructions and templates), reflecting industry best practices, standards and regulations.
Requirements:
- BS/BA in scientific discipline.
- At least 8 years of clinical data management experience in a pharmaceutical/biologics/biotechnology company.
- Experience working in clinical drug development through Phase 3 in an outsourced CRO model while serving as program level DM lead; experience with drug development in rare diseases preferred.
- Expert knowledge of clinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems.
- Experience leading initiatives/projects for SOP, process and standards development within clinical data management.
- Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH, with experience in overseeing study level SDTM implementation and validation.
- Experience working with Medidata Rave.
- Experience using standardized medical terminology, including MedDRA and WHO Drug.
- 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, time and project 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.
Job Tags
Local area, Flexible hours,