Clinical Data Manager

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Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;

one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions:
Terumo Interventional Systems and Terumo Medical Products.

The Clinical Data Manager is responsible for supporting all data management activities for research studies in compliance with departmental SOPs and all regulatory guidelines. The Clinical Data Manager works as an integral part of a cross-functional team throughout the lifecycle of the research study from design through final analysis and study closeout by collaborating with the project teams and providing data review, analytics, and reports.

This position will ensure the clinical study data is collected, handled, and validated in an appropriate and consistent manner to ensure high quality data is delivered to support the statistical analysis.

The Clinical Data Manager is responsible for the following activities: 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).

• Review and provide input to study protocols ensuring data collection requirements are logical, consistent, and support the study endpoints.
• Establish and maintain conducive relationships with cross functional partners to ensure the execution of research studies.
• Partner with therapeutic area personnel to ensure timely and high-quality data management deliverables are produced in support of business goals.
• Accountable and responsible to ensure 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.
• Develop and define edit check specifications.
• Ensure the database design meets the requirements for data entry and reporting as per the specifications.
• Develop and maintain the Data Management Plan throughout the life of the study.
• Communicate with study team members and sites on outstanding items.
• Develop the Completion Guidelines to aid the site personnel to complete the CRFs.
• Perform User Acceptance Testing to ensure the quality and integrity of the database design, edit checks, and programming prior to the database being released to collect data.
• Identify data trends and work with study personnel to ensure high quality data is being collected.

• Identify, document, and implement solutions to data management issues in conjunction with the DM and cross-functional teams.
• Generate and provide study reports to the applicable study team members as appropriate.
• Assist CRAs with preparation for monitoring visits.
• Perform data review and query generation/resolution including third party data reconciliation to ensure the delivery of high-quality data.
• Maintains 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.
• Prepare reports of clinical studies for internal validation and cross validation studies.
• Train internal and external personnel in the CDMS system(s), technology, applications, and Data Management process.
• Demonstrates an understanding of database design, data structure, design constraints and cross-functional needs to support clinical trials.
• Contribute to the development of DM SOPs, Business Guidance, Work…