Terumo Neuro · 15 hours ago
Manager, Clinical Data Management
Aliso Viejo, CA
Full-time
Onsite
Mid, Senior Level
$129K/yr - $170K/yr
7+ years expTerumo Neuro is a leading company in the healthcare sector, and they are seeking a Manager for Clinical Data Management. This role involves overseeing data management activities for research studies, ensuring compliance with regulatory guidelines, and leading a team to deliver high-quality data management deliverables.
Medical Device
Responsibilities
Provide mentoring and coaching to data management team members
Contribute to the development of DM SOPs, Business Guidance, Work Instructions, and Standards
Accountable and responsible for ensuring the delivery of high-quality Data Management deliverables and activities from protocol review through database closure and archiving
Design high quality CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints
Train internal and external personnel in the CDMS system(s), technology, applications, and Data Management process
Maintain complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines
Perform, oversee, complete, and provide accurate review and processing of clinical trial data, including identification, resolution, and clarification of any missing, inconsistent, or clinically questionable data by the study team and/or sites
Generate data management study status/progress overviews
Participate in CRO evaluation
Author, review, and/or approve data management study documents (e.g., eCRF specifications, annotated CRFs Edit Check specifications, eCRF completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained and ready for regulatory inspection
Leverage project management skills to support and oversee multiple projects both insourced and outsourced
Perform other duties and responsibilities as assigned
Qualification
Required
Bachelor's degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience
A minimum of seven (7) years of clinical data management experience in the pharmaceutical, medical device, or Clinical Research Organization setting
A minimum of one (1) year of management or supervisory experience
Proven track record of strong project management skills and experience managing data management activities
Experience in vendor selection and management
Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives
Advanced understanding of clinical data lifecycle including database design, data structure, database development and testing, query management, data quality review, and database lock procedures
Excellent written and verbal communication skills
Strong proficiency with Microsoft Office (e.g., Visio, PowerPoint, Word, Excel, Access, Outlook, Teams, etc.)
Advanced understanding of ICH, ISO, GCP, and GDP guidelines
Preferred
Advanced knowledge in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices
Hands-on experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission
Ability to identify data trends, problems and delays and escalate them appropriately to minimize their impact to the study
Experience in working with CROs/EDC vendors for data management activities
Highly organized with the ability to prioritize and manage multiple activities concurrently
Company
Terumo Neuro
We’re in business to create and deliver innovations that redefine what’s possible in neurovascular treatment, meaningfully advancing both physician practice and patient outcomes.
1001-5000 employees
H1B Sponsorship
Terumo Neuro has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (15)
2023 (7)
2022 (14)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageCompany data provided by crunchbase