Analyst, Data Systems

AbbVie • North Chicago, IL

1d

About The Position

Support the conduct of clinical research trials in accordance with all Regulatory and company requirements. Ensure data collection and transmission systems meet the needs of all end users, including but not limited to the Principal Investigator, clinic personnel, Clinical Project team, monitors and Statistics.

Requirements

• Bachelor’s Degree
• 3 years in Clinical Research
• 3 years' experience with clinical research data systems
• 1-2 years supervisory or leadership role
• This individual must be able to work independently as well as in a team environment and with all levels of personnel within the organization to achieve the desired outcome with little or no guidance.
• Must be able to make sound decisions based on situation at hand, understand when more information is needed to make a sound decision and assume responsibility for the outcome of the decision.
• This position requires a thorough knowledge of data management and the ability to apply that knowledge to a wide variety of situations and to propose potential solutions to management and clients.
• The job requires working knowledge of the research and development of pharmaceuticals, all applicable regulations, GXP, GCDMP, and SOPs and a clear understanding of the effect of his/her decisions on the successful conduct of clinical research studies and subsequent submission to regulatory authorities.

Nice To Haves

• Electronic source systems experience preferred

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Implement and maintain the effectiveness of the data quality system.
• Review Draft Protocols and provide comments on aspects of study that impact study set up, data collection and transmission, and workflow and implications for external client groups (Sponsor/vendor). Offer suggestions for improvement.
• Ensure the design of clinical data collection and management systems used by the ACPRU in the conduct of clinical research trials accurately reflect the protocol requirements and needs of external client groups (Sponsor/vendor).
• Ensure quality and performance metrics are captured in an accurate and timely manner.
• Assist DSSM with accurate documentation, testing, validation and implementation of data management systems and process improvements/upgrades.
• Mentor, coach and train research staff on data management activities and processes, GCP, GCDMP, and applicable regulations.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• short-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level