Manager, Clinical Data Management

Job Description

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). Job duties:

• 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.
  
  

Job Description

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. Job duties:

• 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.
  
  

Salary Range

$129,075-$161344.15

Financial compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

Qualifications

• 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.
  
  

Desired Qualifications

• 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.
  
  

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Posting Country

US - United States