Note: The job is a remote job and is open to candidates in USA. Amylyx Pharmaceuticals is a clinical-stage company focused on developing treatments for diseases with high unmet needs, including post-bariatric hypoglycemia, Wolfram syndrome, and amyotrophic lateral sclerosis. The Senior Manager, Clinical Data Management will oversee clinical data management activities, study timelines, documentation, vendor deliverables, data quality, and audit readiness while supporting clinical database development and data review programming.
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
Skills
- Bachelor's degree or higher in Life Science or related discipline
- Minimum 6 years of clinical data management experience, previous work with CROs and Data Management vendors is required
- 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
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation
- You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote locatio
- Working in a global/cross cultural setting is preferred
- 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
- Certified Clinical Data Manager
Benefits
- Remote work opportunities within the United States
Company Overview