Senior Data Management Lead - Clinical Trials

Alnylam Pharmaceuticals, Inc.; United States; On-site; USD 148,000 - 200,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Clinical Data Management to lead data management activities across all clinical development stages. You will function as a program-level lead and mentor direct reports while ensuring timely, accurate data delivery for studies.

This role oversees database builds, vendor data management, and regulatory submissions, and requires deep knowledge of eClinical systems and CDISC standards. Strong collaboration across functional teams is essential.

Qualifications

• Experience leading global studies through Phase 3 in CRO models.
• Experience developing Data Management SOPs and standards.
• Understanding of 21 CFR Part 11 regulatory expectations.
• Strong communication and mentoring abilities.

Responsibilities

• Act as program-level data management lead for Alnylam studies.
• Oversee database build, edit checks, and UAT with cross-functional teams.
• Monitor CRO data collection, cleaning, coding, and vendor docs.
• Support study timelines and deliverables.
• Provide guidance on data management for regulatory submissions.
• Train and assess performance of direct reports.
• Develop departmental standards and infrastructure strategies.
• Support GCP inspections as a subject matter expert.
• Represent data management in internal and external meetings.
• Collaborate with Biostatistics, Clinical Ops, and QA teams.

Skills

Communication skills

Independent work

Team collaboration

Data management concepts

GCP knowledge

Regulatory awareness

eClinical processes

CDISC-SDTM/CDASH

EDC systems (Medidata Rave)

Documentation standards

Education

BS/BA in scientific discipline

MS or equivalent preferred

Tools

Medidata Rave EDC

MS Office Suite

MS Project

Job description

Alnylam Pharmaceuticals is seeking a Senior Manager, Clinical Data Management to lead data management activities across all clinical development stages. You will function as a program-level lead and mentor direct reports while ensuring timely, accurate data delivery for studies.

This role oversees database builds, vendor data management, and regulatory submissions, and requires deep knowledge of eClinical systems and CDISC standards. Strong collaboration across functional teams is essential.