Responsibilities:
Lead data management activities as a program-level lead data manager in support of 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 & Risk Management (GPSRM), 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.
Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
Mentor and train internal colleagues on data management activities and tasks as needed, fostering a collaborative environment of learning, growth and development.
Participate in the training of external vendors and site staff.
Participate in the drafting and/or review of timelines consistent with goals and ensure all deliverables and milestones are met.
Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
Function as a leader for GCP inspection readiness activities for Data Management and serve as a primary point-of-contact for DM during inspections.
Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.
Requirements:
BS/BA in scientific discipline preferred.
At least 7 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.
NDA/MAA experience.
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