Department: Clinical Development

Job Title: Clinical Data Manager

Location: Andover, MA

TransMedics, Inc., is currently looking for a highly motivated Clinical Data Manager to join our team and help revolutionize transplantation medicine. The successful candidate will perform and manage all data management responsibilities. This is a hands-on role in a fast-paced and dynamic medical device company.

• Responsible for database development and data management using the EDC systems, involving other colleagues and external sources as required
• Design, implement, validate, and maintain the available data systems
• Manage vendors providing data base services
• Participates in protocol development & execution
• Review data handling plans and data checks for clinical studies to ensure they meet regulatory requirements, and good clinical practice
• Coordinates database requirements for studies with clinical project managers and/or clinical research associates
• May perform design and programming tasks in SAS
• Ensures data integrity for all studies
• Develop programs that help in identifying data issues and outliers and communicate the findings to team
• Ensure data cleaning, editing and verification, and database lock
• Develop programs to load data from external sources
• Perform interim and final databases audits.
• Supports relationships with external investigators and staff
• Align priorities with clinical project managers to meet timelines
• Resolve database-related issues at study sites
• Develop and review Standard Operating Procedures and Work Instructions
• Assist in the development of systems for sharing data within the company
• Stay informed on current topics and new developments in clinical data management

Requirements:

• Minimum of 3-5 years of Clinical Data Management experience
• Knowledge of and expertise in using Electronic Data Capture (EDC) systems, general database requirement and data management for clinical trials required.
• Experience in clinical study design, protocols and electronic case report forms required.
• Knowledge of clinical research in medical device preferred
• Statistical expertise and working knowledge of SAS preferred
• Ability to understand and comply with regulatory, ICH and GCP guidelines and internal Standard Operating Procedures
• Detail oriented and well organized.
• Works well on project team and cross-disciplinary environment
• Ability to multitasking and to prioritize conflicting tasks in fast-paced environment
• Technical and non-technical communication skills, both verbal and written

Headquartered in Andover, Massachusetts, TransMedics™ is a medical device company founded in 1998 to address the unmet need for better, more effective organ transplant technologies. Our mission is to enable more patients with end stage organ failure to benefit from the accepted medical standard of care - organ transplantation. We have developed the first portable warm blood perfusion system that allows for a new type of organ transplant, called a living organ transplant, which maintains organs in a warm and functioning state outside of the body during transport from organ donor to recipient. We are revolutionizing the field of transplantation medicine by increasing organ availability and improving outcomes for the growing population of patients with end stage organ failure in need of a transplant, bridging the widening gap between the number of organs available and the number of recipients awaiting transplants.

Join us, and help bring the gift of life to patients in need around the world. Along with an exceptional culture, we offer a competitive compensation and benefits package, an entrepreneurial environment, and the opportunity for employees to enhance their careers and achieve greater levels of responsibility as the company grows. TransMedics is an Equal Opportunity Employer. For more information please visit our website at www.transmedics.com.

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