Senior Clinical Data Manager – Lead SDTM & EDC Expert

cGxPServe; San Francisco (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

cGxPServe is seeking a Clinical Data Manager in San Francisco, CA to oversee clinical data management activities in support of Alnylam clinical studies. The successful candidate will lead database build activities and monitor data collection and cleaning by vendors. An expertise of at least 8 years in clinical data management and familiarity with regulatory standards is essential.

The role requires strong project management skills, excellent communication abilities, and experience with clinical trial systems. You will collaborate across various functions while ensuring compliance with industry standards.

Qualifications

• At least 8 years of clinical data management experience.
• Experience in drug development through Phase 3 in an outsourced CRO model.
• Knowledge of CDISC, SDTM, and CDASH standards.

Responsibilities

• Lead data management activities for Alnylam clinical studies.
• Monitor data collection and coding by vendors.
• Collaborate with teams including Biostatistics and Clinical Operations.

Skills

Clinical data management

Cross-functional collaboration

Regulatory knowledge

Project management

Excellent communication skills

Medidata Rave

Education

BS/BA in scientific discipline

Tools

MSOffice Suite

MedDRA

WHO Drug

Job description

cGxPServe is seeking a Clinical Data Manager in San Francisco, CA to oversee clinical data management activities in support of Alnylam clinical studies. The successful candidate will lead database build activities and monitor data collection and cleaning by vendors. An expertise of at least 8 years in clinical data management and familiarity with regulatory standards is essential.

The role requires strong project management skills, excellent communication abilities, and experience with clinical trial systems. You will collaborate across various functions while ensuring compliance with industry standards.