The Sr. Clinical Data Analyst is responsible for assisting Clinical Data Managers and ensuring that data management services (clinical data and data structure) are delivered in a complete, consistent, accurate and high quality manner for assigned Abiomed Clinical Study(ies). The Sr. Clinical Data Analyst works closely with Senior Clinical Data Manager and Clinical Program Manager(s), and Clinical Research Associates, to execute the trial. She/he may need to engage and work closely with CROs and Vendors that execute the data management and Core Lab services.
Primary Duties and Responsibilities:
Works independently to provide data review listings as requested by clinical and medical teams
Reviews data and manages queries based on programmed edit checks and Data Management Plan
Reviews data listings to clean data and issue queries if needed
Performs external vendor (i.e. Core Labs) data processing and external vendor data reconciliation
Performs EDC User Acceptance Testing (UAT)
Contributes to preparation and maintenance of data management documents
Works with clinical programming team/vendor to achieve eCRF development
Supports and provides cross-functional collaboration and communications to increase quality of data management deliverables
Provides data review metrics, query metrics and other metrics as requested
Reviews, analyzes, validates and maintains clinical trial data ensuring consistency, integrity and accuracy
Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others to meet project deliverables and timelines
Utilizes reports to track study progress and ensure timeliness and quality expectations are met
Develops, tracks, analyze and reports, as applicable, on data management performance metrics
Participates in the review of Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Data Management Plans, Communication Plans).
Ensures the clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock
Identifies potential project risks and drafts mitigation strategies with the internal project team to proactively address issues
Maintains a consistent, manageable workflow for DM project team by monitoring enrollment information and communicating with project team to actively influence data collection
Capable of handling studies that are complex in scope and volume
BS degree in Life Sciences, Computer Sciences, Mathematics or related medical/scientific field; MS or graduate degree preferred
Minimum of four years’ data management experience in pharmaceutical or biotechnology; prior medical device experience highly desirable
Experience with Electronic Data Capture (EDC) process and platforms such as RaveX, Veeva EDC; experience with Data Review in JReview or other review tools
CRO/vendor management experience required
Expertise with GCP and regulatory compliance guidelines for clinical trials required
Must be computer savvy and highly proficient in Microsoft Office
Competence in SAS programming a plus
High attention to details and accuracy; able to work independently and to prioritize and organize work to meet deadlines
Excellent interpersonal communication skills; Works effectively on cross-functional teams
~5% travel to Vendors
Internal Number: 4533
About Abiomed, Inc.
Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,400 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.