Senior Manager, Clinical Data Management at Amylyx · LumiJobs

Responsibilities

The Clinical Data Management team at Amylyx Pharmaceuticals is seeking an Associate Director, Clinical Data Programmer. This individual will work collaboratively cross-functionally to provide hands-on data management support, programming support and technical leadership to develop, maintain, validate the clinical database, and run computer programs that access, visualize, and report clinical trial data, in accordance with various clinical plans, ICH guidelines, and applicable regulatory requirements. As an Associate Director of Clinical Data Programming, you will be required to program in the appropriate languages to create both textual and graphic displays that facilitate data cleaning and review.
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

Senior Manager, Clinical Data Management

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Amylyx

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