Senior Manager, Clinical Data Management & Global Trials

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 145,000 - 196,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off and holidays

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Clinical Data Management to lead data management activities across studies. The role reports to the Director/Associate Director and involves cross-functional collaboration with Biostatistics, Clinical Operations, Regulatory Affairs and CROs.

Responsibilities include program-level data management leadership, database build oversight, vendor management, regulatory submissions support, and staff coaching. Strong GCP/CDISC experience required.

Qualifications

• BSc/BA in scientific discipline, MS preferred.
• At least 10 years related experience in a pharmaceutical/biologics/biotechnology company.
• Experience managing global studies through Phase 3 in outsourced CRO model; rare disease experience preferred.
• Experience managing direct reports and providing performance reviews.
• Experience developing Data Management SOPs and standards.
• Understanding of ICH GCP and regulatory requirements for clinical data systems; CDISC standards familiarity.

Responsibilities

• Function as program level data management lead in support of Alnylam clinical studies, as individual contributor and manager of direct reports.
• Lead oversight of database build activities, including cross-functional review of eCRF content and UAT.
• Monitor data collection, cleaning and coding by CROs; oversee study database lock activities.
• Participate in drafting/timelines and ensure deliverables and milestones are met.
• Provide strategic guidance to reports and cross-functional teams on data management for database locks and regulatory submissions.
• Train, mentor and oversee direct reports; conduct performance reviews.

Education

BSc/BA in scientific discipline, MS preferred

Tools

Medidata Rave

MS Office Suite

MS Project

Job description

Alnylam Pharmaceuticals is seeking a Senior Manager, Clinical Data Management to lead data management activities across studies. The role reports to the Director/Associate Director and involves cross-functional collaboration with Biostatistics, Clinical Operations, Regulatory Affairs and CROs.

Responsibilities include program-level data management leadership, database build oversight, vendor management, regulatory submissions support, and staff coaching. Strong GCP/CDISC experience required.