Scientist Tech Support

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Summary:

This role is responsible for clinical data management (CDM) activities and operations for new and ongoing clinical research studies including the creation of, or contribution to, the Data Management Plan (DMP), the CDM start-up activities required to initiate a new clinical trial, as well as the timely creation of queries and resolution of issues related to the ongoing conduct and closeout of clinical trials.

Core Job Responsibilities:

• Participates in the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians. · Coordinates activities by working with Clinical Scientists, Clinical Research Associates, Clinical Safety Monitors, Systems Analysts, QC Analysts & Standards Librarian.
• May draft Data Management Plans and Data Review Plans as required. · Assists with the development of standard and non-standard edit check specifications by utilizing clinical knowledge to create the parameters surrounding data items. · Assists with the preparation of test data to verify functionality of edit checks in the clinical trial database. · Assists and may provide input to CRF/eCRF design and address technical issues and edit check programming, as well as contributes to the development of data management reports of clinical data. · May perform Clinical Data Management activities by using Clinical knowledge, data listings and manual review of eCRFs to issue queries and clean data as required.
• Contributes to the monitoring of data quality during study conduct.
• Provides information on issues along with proposed solutions · Assists to ensure data snapshots are ready for analysis by following the guidelines established in the DMP and/or applicable SOPs. · Assists with database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs. · Assists with archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs.
• Participates in the preparation and presentation of data management activities by evaluating and testing new systems and by participating in task force initiatives.

Accountability/Scope:

• Coordinates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
• May begin to demonstrate basic project management skills by acting as a project lead on small, well defined projects.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• With supervisor, exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources.

Qualifications:

• Bachelor's degree plus 0- 2 years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.
• Clinical Data Management background/experience preferred.
• Working understanding of Electronic Data Capture (EDC) concepts and techniques and of clinical trial principles is preferred.
• Experience with PhaseForward's InForm EDC application is preferred.
• Prior hands-on experience with clinical data querying, issues resolution, and coordination of CDM activities preferred.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Working knowledge and application of business concepts, procedures and practices.
• Working understanding of the implications of applicable laws and regulations governing Clinical Research.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.

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