Remote Senior Clinical Data Programming Leader

Amylyx Pharmaceuticals; Cambridge (MA); On-site; USD 156,000 - 175,000; Full time

Job summary

Amylyx Pharmaceuticals in Cambridge, MA, is seeking an Associate Director of Clinical Data Programming to lead hands-on data programming and CDM activities across global trials. The role collaborates with Biometrics, Clinical Operations, Safety, and Regulatory teams to ensure data quality and regulatory compliance.

You will oversee CDM documentation, eCRF development, UAT planning, vendor management, and collaboration with CROs and data vendors to meet study milestones, while supporting audit

Qualifications

• Bachelor’s degree or higher in Life Science or related discipline.
• Minimum 6 years clinical data management experience with CROs/vendors.
• Solid knowledge of FDA/ICH regulations and CDISC standards.
• Excellent communication and project management skills.
• Experience with eTMFs and CDM documentation.
• Ability to work in a global cross‑functional environment.
• Experience with study oversight and vendor relationships.

Responsibilities

• Provide project-level oversight of clinical data management activities.
• Develop timelines and monitor data deliverables with teams and vendors.
• Oversee study CDM documentation and risk mitigation.
• Lead CRO DM vendor coordination to meet milestones.
• Perform CDM testing including UAT plans and scripts.
• Coordinate with Biometrics, Safety, Regulatory, and Ops teams.
• Support audit readiness and regulatory inspections.

Skills

CDISC/CDASH/SDTM

Vendor management

Regulatory knowledge

Communication

CDM documentation

Education

Bachelor’s degree in Life Science or related discipline

Tools

Medidata Rave

Job description

Amylyx Pharmaceuticals in Cambridge, MA, is seeking an Associate Director of Clinical Data Programming to lead hands-on data programming and CDM activities across global trials. The role collaborates with Biometrics, Clinical Operations, Safety, and Regulatory teams to ensure data quality and regulatory compliance.

You will oversee CDM documentation, eCRF development, UAT planning, vendor management, and collaboration with CROs and data vendors to meet study milestones, while supporting audit