Alnylam Pharmaceuticals · 1 month ago
Senior Clinical Data Manager
Cambridge, MA
Full-time
Hybrid
Mid, Senior Level
$127K/yr - $172K/yr
7+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, committed to transforming the lives of individuals with rare and common diseases. The Senior Clinical Data Manager will lead data management activities in support of clinical studies, ensuring data integrity and compliance throughout the clinical drug development process.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Contribute to data management activities as a lead study 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 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
Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
Qualification
Required
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 Oracle InForm and 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
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
2026-01-13
2026-01-13
Company data provided by crunchbase