Terumo Neuro · 7 hours ago
Manager, Clinical Data Management
Aliso Viejo, CA
Full-time
Onsite
Mid, Senior Level
$129K/yr - $161K/yr
7+ years expTerumo Neuro is a company focused on innovative healthcare solutions. The Manager of Clinical Data Management will lead and oversee all data management activities for research studies, ensuring compliance with regulatory guidelines and delivering high-quality data management deliverables.
Medical Device
Responsibilities
Responsible for leading and overseeing all data management activities for research studies from study start-up to database lock in compliance with departmental SOPs and regulatory guidelines
Responsible for executing, overseeing, and synchronizing the following activities: leading and coordinating initiatives to evaluate and implement efficiencies, protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF)
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
Responsible for establishing, preparing, and leading the strategy for worldwide product approval submission activities
As a recognized expert, manage multiple large projects or processes
Responsible for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices
Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives
Identify regulatory requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to solutions
Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects and processes that span outside of immediate job area
Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy
Communicate with regulatory agencies on administrative and routine matters
Document, consolidate, and maintain verbal and written communication with the regulatory agencies
Review change order documents and ascertain impact on current regulatory approvals
Review promotional material and labeling for regulatory compliance
Develop and maintain regulatory files and records
Support and contribute into developing, editing, or revising regulatory processes
Lead training for global regulatory processes and system implementations
Build team cohesiveness by influencing and mentoring team members
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
Perform additional duties 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