Senior Clinical Data Manager
The CDM will contribute to data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the Associate Director, Data Management.
Summary of Key Responsibilities:
- Contribute to data management activities in support of Alnylam clinical studies, including:
- eCRF development by leading cross-functional reviews of eCRF content;
- Database build activities, including review of edit check specifications and performance of user acceptance testing;
- Monitoring 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, Drug Safety and Pharmacovigilance; 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, edit check specifications, external data transfer specifications and other study documentation;
- 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 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;
- 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, with at least 4 years related experience in a pharmaceutical/biologics/biotechnology company;
- 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 EDC;
- 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.
Desired Experience
- Experience with global studies, utilizing an outsourced CRO model;
- Experience in clinical drug development through phase 3;
- Experience with drug development in rare genetic diseases;
- Education or work experience in a health-related field.
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