Senior Manager, Clinical Data Management

📋 Description

• Provide project-level oversight of clinical data management activities, monitors and reports on
• Develops project timeline and monitors data deliverables for all assigned studies in collaboration
• Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF
• Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User
• Develops risk mitigation or action plans and oversees execution when appropriate

🎯 Requirements

• Bachelor’s degree or higher in Life Science or related discipline
• Minimum of 6 years of clinical data management experience, previous work with CROs and Data
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines
• Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH
• Excellent interpersonal, communication, and organizational skills with the ability to manage
• Proven ability to build relationships and manage expectations with CROs/external vendors

🎁 Benefits

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and
• You must have access to work in setting that meets all requirements of the role (including privacy