Amylyx Pharmaceuticals is hiring a
Lead Clinical Data Management

Summary

Join a pharmaceutical company dedicated to improving lives with neurodegenerative diseases by addressing the root cause. As Lead, Clinical Data Management, you'll provide project-level oversight of clinical data management activities and ensure timely execution of clinical trials.

Requirements

• Bachelor’s degree in Life Science or related discipline required
• 8-10 years of clinical data management experience, previous work with CROs and Data Management vendors is required, working in a global/cross cultural setting is preferred
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines
• Strong knowledge with CDISC (CDASH/SDTM), medical dictionary coding standards, FDA and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices
• Excellent interpersonal, communication, and organizational skills with the ability to manage multiple programs and processes simultaneously in a fast paced, team-based environment
• Proven ability to build relationships and manage expectations with CROs/external vendors
• Experience with eTMFs pertaining to CDM documentation

Responsibilities

• Provide project-level oversight of clinical data management activities, monitors and reports on overall study progress
• Develops project timeline and monitors data deliverables for all assigned studies in collaboration with cross functional team members and vendors
• Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans – identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF)
• Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
• Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable
• Develops risk mitigation or action plans and oversees execution when appropriate
• Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel
• Liaise directly with internal customers (Biometrics, Clinical Operations, Safety/Pharmacovigilance, Regulatory Affairs, etc.) and external customers (CROs, external data vendors, etc.)
• Oversee the performance and quality issues with vendors and escalates to management and develops appropriate risk mitigation as needed
• Support study-level audit and inspection readiness activities as needed

Preferred Qualifications

• Experience in managing data management tasks for Phase III clinical trials
• Experience in supporting study-level audits and regulatory inspections
• Expertise with Medidata Rave EDC system