Remote Lead, Clinical Data Management

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 148,000 - 200,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking a Principal Clinical Data Manager, Data Management, to lead data management activities across all stages of clinical drug development. This role reports to the Director, Data Management or the Associate Director, Data Management.

You will oversee database build activities, data review plans, SDTM validation, and data transfers with CROs and vendors, while ensuring compliance with ICH GCP and 21 CFR Part 11.

Qualifications

• BS/BA in scientific discipline.
• At least 10 years of clinical data management experience.
• Experience with CRO model and Phase 3 studies; rare diseases preferred.
• Expert knowledge of eClinical processes and EDC systems.
• Knowledge of CDISC, SDTM, and CDASH; SDTM validation experience.
• Experience with Medidata Rave.
• Experience with MedDRA and WHODrug.
• Strong MS Office and MS Project skills.
• Excellent written and oral communications skills.
• ICH GCP and 21 CFR Part 11 knowledge.

Responsibilities

• Lead data management activities as a program-level lead DM.
• Oversee database builds including CRF content reviews and UAT.
• Monitor data collection, coding, and cleaning by vendors.
• Oversee database lock activities and archiving of study data.
• Collaborate with cross-functional teams and vendors on data requirements.
• Establish cross-functional data review plans and data transfers.
• Review CRO data management plans and SDTM validation activities.
• Coordinate feedback to CROs and drive issue resolution.
• Develop and implement departmental workflows and templates.

Skills

Communication skills

Project management

Time management

Team collaboration

Education

BS/BA in scientific discipline

Tools

Medidata Rave

MS Office

MS Project

Job description

Alnylam Pharmaceuticals is seeking a Principal Clinical Data Manager, Data Management, to lead data management activities across all stages of clinical drug development. This role reports to the Director, Data Management or the Associate Director, Data Management.

You will oversee database build activities, data review plans, SDTM validation, and data transfers with CROs and vendors, while ensuring compliance with ICH GCP and 21 CFR Part 11.