The Senior Clinical Data Manager reports to the Director, Clinical Programs & Clinical Operations and is responsible for executing and overseeing Clinical Data Management (DM) operational activities, ensuring compliance with protocols, timelines, good clinical practice, and regulations (US & EU). In addition, they may oversee work of Clinical Data Analysts assigned to their study and data management services which are outsourced to data management partners, EDC, randomization, and imaging vendors in addition to data provided by Core Labs.
Principle Duties and Responsibilities:
Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget
Coordinate and participate in the development of the clinical data model and/or database design according to protocol requirements and study specifications
Represent Data Management and actively participate on Clinical Study Core Team meetings for all study activities
Lead all DM functional activities using established templates/processes as applicable
Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts including risk mitigation strategies
Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion/monitoring conventions
Develops and test data management system edit/data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities
Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
Develops specification and collaborates with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study.
Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan
Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations
Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary
Assist in the creation and review of departmental SOPs, Work Instructions, and training materials
Bachelor’s degree in a relevant scientific discipline or equivalent; Medical and/or advanced degree preferred
Minimum of 7 years of data management experience in the medical device, pharmaceutical, biotech and/or CRO industries, with experience in managing data from First in Man through Post Marketing clinical trials.
Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus
Prior knowledge and experience with Medidata Suite products (RAVE EDC, TSDV, CTMS) required. Experience with various other clinical databases preferred (e.g., Oracle Inform) and key technologies (e.g., SAS, Scanning/Imaging, IVRS/IWRS, ePRO)
Proficient on evaluating, testing, and managing new data standards, technologies, and systems.
Knowledge of FDA and EU regulations, GCP, GCDMP and ICH guidelines required specifically as it relates to ensuring compliance with these regulations and guidelines for audit readiness
Able to work collaboratively and demonstrate leadership skills to manage indirect staff, lead and motivate others
Excellent communication, written and interpersonal skills
Self-sufficient and able to prioritize and work on multiple tasks & studies with minimal oversight
Able to develop project management objectives, as needed
Proficient in MS Word, Excel, Outlook, and PowerPoint.
Knowledge of Business Objects, J Review, Spotfire preferred
SAS and R programming and proficiency in other statistical packages is a plus
Internal Number: 6713
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.