Delivering on the promise of medical innovation begins at Boston Scientific.

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Clinical Data Manager

Job Description:
General Summary:
A Clinical Data Manager has mastered basic clinical data management skills. The CDMI begins to develop more complex data management skills, such as Case Report Form design and Data Management Plan development.
Minimum Education & Experience:
Education: Bachelor’s Degree preferred.
Professional Experience Years: 2-4 years of clinical research experience.
Duties and Responsibilities:
?Lead a less complex study or a study with a relatively low number of subjects during study conduct.
?Participate in developing study start up activities such as Case Report Form (CRF) design and Database Specifications/Edit Check Specifications.
?Review and provide feedback to Clinical core team documents.
?Sit on a Clinical Core Team and actively participate in team meetings. Obtain input from Manager 1 and 2 for clinical data management issues.
?Train the CDM and/or Clinical Core Team in the study specific clinical data management processes.
?Train Investigators and Coordinators at Investigator Meeting in the Case Report Form, the EDC system, and the completion guidelines.
?Provide 1:1 training to new or junior staff in basic clinical data management tasks.
?Review the work of CDM I and provide feedback.
?Complaint reporting.
?Identify CAR/CAPA.
?Execute CAR/CAPA.
?Ensure up to date training
?Review data. Begin to identify data trends on a site level.
?Query/DCF generation. Begin to identify appropriate standard query/DCF text.
?Integrate or close queries/DCFs for all categories on a project.
?Perform UAT and begin to design UAT plan.
?Lead team through Data Entry Verification Audit (DEVA) process.
?Follow applicable processes within DMP for a project. Draft the DMP. Suggest updates or improvements to the DMP.
?Develop basic status reports and utilize status reports to determine follow-up action.
?Work with various vendors to troubleshoot issues.
?Identify processes for improvement related to project tasks, and start to investigate a possible solution.
?Participates in development of a new process/revision of an existing process on a task force.
?Identify possible revision in Work Instruction (WI) or Standard Operating Procedure (SOP).
?Code verbatim terms.
?Collaborate with Medical Sciences for coding review and approval.
Personal Skills/Attributes/Qualifications:
?Demonstrates a passion for learning, sharing and discovering new information. Builds solid relationships of trust across the organization.
?Sets high standards for performance for both self and others. Displays a sense of urgency and produces results. Strong achievement orientation.
?Conveys enthusiasm for work and initiates activities without prompting. Seeks out new challenges and puts in extra effort to accomplish results. Willing to use opportunities to increase efficiency and effectiveness.
?Fosters an atmosphere of open communication. Speaks and presents effectively and listens to what others have to say.
?Supports and builds collaborative, respectful relationships with the team and across the organization. Embraces differences and treats all members of BSC with respect.
?The ability to identify, use, control and manage interpersonal skills.
?Identifies, defines and evaluates problems. Uses knowledge, experience and judgment to problem solve appropriately for the role.
?Understands and interprets technical, scientific, and clinical information and applies that understanding to product approval activities.
?Activities related to targeting, building and maintaining relationships with customers.
?Good at managing and figuring out processes necessary to get things done. Understand how to separate and combine tasks into efficient work flow. Resulting in effectively managing priorities and completing deliverables on time.
?Utilizes data, knowledge and experience to deliver information to enable scientific and business objectives.

Job Experience:
Bachelor’s Degree preferred.
2-4 years of clinical research experience.

Minimum Education Required: Associate

Years of Experience Required: 3-5 Years

Expected Travel Time: None