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.
Bachelor's Degree
3 years in Clinical Research
3 years' experience with clinical research data systems
1-2 years supervisory or leadership role
Electronic source systems experience preferred
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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
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.