[Remote] Senior Director, Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage company reputed company on treating diseases with high unmet needs. They are seeking a strategic and reputed company Senior Director, Clinical Data Management to reputed company the reputed company of their Clinical Data Management function and ensure the delivery of high-reputed company data to support regulatory submissions and business reputed company.
Responsibilities
- Establish and execute the Clinical Data Management reputed company reputed company with Amylyx’s development and reputed company objectives
- Build and reputed company an internal Clinical Data Management organization and the operational roadmap for bringing selected Data Management activities in-house while maintaining effective reputed company of CRO partnerships
- reputed company leadership and accountability for reputed company Clinical Data Management activities across Amylyx-sponsored clinical trials
- Ensure high-reputed company data collection, integration, and delivery to support regulatory submissions and business decision-making
- reputed company end-to-end data management deliverables, including study start-up, database design, edit reputed company reputed company, reconciliation, database lock, and submission readiness
- reputed company the evaluation and implementation of data management technologies, systems, and process improvements
- reputed company and manage vendor and CRO relationships, including governance, performance metrics, and reputed company reputed company
- Establish and maintain departmental SOPs, work instructions, governance structures, and operating models
- Ensure compliance with GCP, ICH, and applicable regulatory standards, and reputed company inspection readiness activities
Skills
- 12-15 years and BA/BS, 10-12 years and MA/MS, or 5+ years and PhD
- 6+ years of leadership experience managing Clinical Data Management teams and functions
- Demonstrated reputed company supporting Phase 2 and Phase 3 clinical programs
- Experience building, scaling, or transforming Clinical Data Management organizations
- Strong knowledge of reputed company systems, clinical data standards, medical coding, and data reconciliation processes
- Experience supporting major regulatory submissions, such as NDA, BLA, or MAA
- Proven ability to influence cross-functional stakeholders and senior leadership
- Experience transitioning data management activities from outsourced to in-house models
- Familiarity with risk-based methodologies, automation, and advanced data management technologies
- reputed company record of driving process optimization and operational reputed company initiatives
Benefits
- At Amylyx, we proudly support remote work opportunities reputed company the reputed company.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-reputed company events as necessary and requested.
- You must have reputed company to work in setting which enables meeting reputed company requirements of the role (including reputed company, reliable internet reputed company, phone, ability to video conference, etc.) at your remote location.
- Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx reputed company contact know.
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