Senior Manager, Clinical Data Management
The Senior Manager, Clinical Data Management will lead and contribute to data management activities in support of Alnylam studies across all stages of clinical drug development.
Summary of Key Responsibilities
- Function as program level data management lead in support of Alnylam clinical studies, operating both as an individual contributor and manager of direct reports;
- Lead oversight of database build activities, including cross-functional review of eCRF content, review of edit check specifications, and performance of user acceptance testing
- Monitor data collection, cleaning and coding by CROs via the execution of internal data review plans and review of all vendor data management documentation; provide oversight of all study database lock activities;
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met;
- Provide strategic guidance to direct reports and internal cross-functional team members regarding data management activities in support of database locks, regulatory submissions and/or other key study deliverables
- Train, mentor and oversee work activities of direct reports; provide regular performance review assessments
- Author and contribute to development and implementation of departmental standards and infrastructure strategy, such as SOPs, data collection standards and document templates, consistent with industry best practices;
- Support GCP inspection readiness and participate as subject matter expert in GCP inspections;
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors;
- Collaborate effectively 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 laboratories, and other vendors;
- Review clinical protocols/amendments, clinical study reports, etc.;
- Demonstrate clear alignment with Alnylam Core Values including Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
Qualifications
- BS/BA in scientific discipline, MS or equivalent preferred
- At least 10 years related experience in a pharmaceutical/biologics/biotechnology company;
- Extensive experience managing global studies through Phase 3 in an outsourced CRO model from start-up through close-out; experience with drug development in rare genetic diseases preferred;
- Experience managing direct reports and providing performance reviews and career development guidance;
- Experience developing Data Management SOPs and standards;
- 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;
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial data/Data Management Systems;
- Expert knowledge and understanding of regulations and industry-adopted data standards, such as CDISC-SDTM and CDASH;
- Experience using standardized medical terminology, including MedDRA and WHODrug;
- Experience working with Medidata Rave EDC system;
- Experience working with MS Office Suite (Excel, Word and PowerPoint), familiarity with MS Project;
- Excellent written and oral communication skills;
- Highly motivated and flexible, with excellent organizational skills;
- Ability to work independently and as part of a multi-disciplinary team
- NDA/MAA submission experience preferred
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