Abbott Laboratories Saint Paul , MN 55102
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Clinical Database Specialist (CDS) is responsible for performing data management tasks, including clinical study database design. The CDS is capable of supporting clinical trials from initial data collection to database lock and closure with general mentoring and coaching from data management peers and management.
PRIMARY DUTIES AND RESPONSIBILITIES
Represents Data Management on Clinical Project Teams through the following:
Attend Clinical Project Team meetings to gather business need requirements and translate to technical requirements
Partner with other shared service functions such as Safety, Core Lab, etc. to gather business need requirements and translate to technical requirements
Train database End Users (internal and external users) on the database and/or maintain automated database training system
Capture and maintain Database and Systems training records
Assists in FDA and Quality audits that involve Clinical Database and Data Management
Lead development and quality control (QC) of data management documents including data management plans, data review guidelines, and database validation protocols
Follows and implements data management standards and best practices and assures Standard Operating Procedures are followed for Data Management activities
Contributes to the development and maintenance of Clinical Database systems, including EDC, Edit Checks, Reporting, Study Notifications, Security, etc. through the following:
Partners with Clinical Team to translate Site Contracts to programmatic payment rules
Understands clinical trial payment systems and process
Partner closely with DM Management, Database Developers/Analysts, and Programmers to drive database and system deliverables
Translate business requirements into technical requirements for eCRFs, edit checks, study notifications and customizations in the study database
Perform and document functional and/or user acceptance testing on study databases, reports, study notifications, and database customizations
Ensure that appropriate data validation (edit check) specifications and quality control checks are implemented per study needs
Effectively communicate with the Clinical Project Team and other key stakeholders regarding the deliverable, including timeline, workaround, etc.
Process database accounts and reviews accounts regularly to ensure integrity of database access and security
Lead data cleaning and data freeze/lock efforts for regulatory submissions and other business needs as requested by the Clinical Project Team through the following:
Lead data review meetings with the Clinical Project Team and Statistics to identify data cleaning issues and strategize cleaning efforts
Project plan interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved
Coordinate and ensure completion of all aspects of data review, including running validation procedures, issuing queries, database QC, SAE Reconciliation, medical coding, and database closure activities per work instructions and SOPs as applicable
Design tools and reports to document data review and assist in data cleaning activities
Lead and document data freeze activities with the Clinical Project team, Biostatistics, and SAS programmer
Utilize existing tools and database to identify data issues and drive resolutions with the Clinical Project Team in a timely manner
Perform other duties as assigned.
General knowledge of clinical study lifecycle from protocol design to database development and study closure.
Proficiency with using EDC databases, preferably Clindex.
Experience working under Good Clinical Practices, Good Clinical Data Management Practices, and other FDA regulations and guidelines is required.
Demonstrated solid oral and written communication skills and analytical/problem-solving skills are essential as is the ability to clearly communicate basic data management concepts to those outside data management.
Must be able to effectively manage multiple projects and timelines.
Must be able to travel up to 5% per year.
Requires the ability to sit or stand while working on a computer for an extended period.
Bachelor's degree (REQUIRED) in computer sciences or a scientific discipline with a minimum of 2+ years of experience in a medical device clinical research or data management position is required.
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
JOB FAMILY:Medical & Scientific Affairs
LOCATION:United States > Minnesota : 177 East County Rd B
TRAVEL:Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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EEO is the Law link