Senior Manager, Clinical Data Management

The Opportunity

The Senior Manager, Clinical Data Management provides project oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming. The Senior Manager, Clinical Data Management is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the primary Data Management (DM) representative to the study management team. The successful candidate partners with key study team members to facilitate implementation of a robust and clear data strategy plan for the studies assigned; works with DM leads at CROs and other vendors to ensure timely execution. This position reports to the Senior Director, Clinical Data Management.

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

Requirements

• 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, 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

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
• Certified Clinical Data Manager

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• 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 location