Sr Clinical Data Manager 6/3/2020
JOB DESCRIPTIONAPPLY Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: Patients First. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed s 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
The Senior Clinical Data Manager is responsible for executing and overseeing Data Management (DM) operational activities, ensuring compliance with the protocols, corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide study data.
* Serves as an active member of study operation teams.
* Works with other functions to develop timelines and ensure that clinical data management deadlines are met.
* Oversee and manage DM related activities 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.
* Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
* Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
* Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion/monitoring conventions
* Develop 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
* Participate with the study operation teams for all study activities and lead all DM functional activities using established templates/processes as applicable.
* Develops UAT plan and requirements for study databases and revisions; performs testing in accordance with SOPs and UAT plan.
* Develops study-specific eCRF Completion Guidelines.
* Creates and maintains data management documentation.
* Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan.
* May perform medical terminology coding with support from other team members.
* Helps design listings in support of clinical and medical review of data.
* Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
* Trains other personnel on CRFs and EDC, as needed.
* Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards.
* 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.
* Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed.
* Ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media, at all times.
* Able to cultivate effective and productive working relationships with colleagues, subordinates, vendors, and management.
* Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary.
* Assist with departmental SOP development and maintenance.
* 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)
* Knowledge of Business Objects, J Review, Spotfire preferred
* Proficient on evaluating, testing, and managing new data standards, technologies, and systems.
* Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required specifically as it relates to ensuring compliance with these regulations and guidelines for audit readiness
* SAS and R programming and proficiency in other statistical packages is a plus
* Excellent communication, written and interpersonal skills
* Self-sufficient and able to work with minimal oversight
* Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed
* Able to prioritize and handle multiple tasks and studies simultaneously
* Able to manage indirect staff, as needed. Ability to develop project management objectives, as needed
* Proficiency with MS Word, Excel, Outlook, and PowerPoint.
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.