Senior Clinical Data Manager — Program Lead

Alnylam Pharmaceuticals

United States

On-site

USD 148,000 - 200,000

Full time

14 days+

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Job summary

The Principal Clinical Data Manager, Data Management will lead and contribute to data management activities in support of Alnylam studies across all stages of clinical drug development. This position reports to the Director, Data Management or Associate Director, Data Management.

Responsibilities include leading program-level data management, database build and cross-functional reviews, vendor oversight, SDTM validation, and development of SOPs and templates to align with industry standards and

Qualifications

BS/BA in scientific discipline.
7-9 years of clinical data management experience in pharma/biologics/biotechnology.
Experience leading data management initiatives and SOPs in CRO-enabled environments.
Expert knowledge of CDISC standards (SDTM/CDASH) and 21 CFR Part 11.
Experience with Medidata Rave and data management systems.

Responsibilities

Lead data management activities as a program-level DM lead.
Lead database build activities and vendor management.
Monitor data collection, coding, and cleaning by vendors and review study metrics.
Oversee database lock activities and archiving of study data.
Collaborate with cross-functional teams including Biostatistics, Regulatory Affairs, and CROs; oversee SDTM validation with Statistical Programming.