Analyst, Data Systems

PowerToFly; North Chicago (IL); On-site; USD 110,000 - 140,000; Full time

Job summary

AbbVie is seeking a data management professional to support clinical research trials in a regulated environment. The role emphasizes data quality systems, protocol-driven data collection, and collaboration with cross-functional teams to ensure compliant data management throughout studies.

The candidate will mentor staff and apply GCP/GCDMP knowledge to ensure high-quality data for regulatory submissions, while maintaining adherence to SOPs and industry standards.

Qualifications

• Bachelor's degree required; clinical research experience preferred.
• Minimum 3 years in clinical research.
• 3 years' experience with clinical data systems.
• 1–2 years supervisory or leadership experience.
• Ability to work independently with minimal guidance.
• Strong knowledge of GCP, GCDMP, SOPs and pharma regulations.

Responsibilities

• Ensure compliance with applicable corporate and divisional policies.
• Implement and maintain the data quality system.
• Review protocols and provide comments on study setup and data collection.
• Ensure data collection/management systems reflect protocol requirements.
• Ensure quality and performance metrics are captured accurately.
• Assist with documentation, testing, validation and implementation of data management systems.
• Mentor and train staff on data management and GCP/GCDMP.

Skills

Clinical Research

Data Management Systems

Leadership

GCP/GCDMP knowledge

Pharma regulations

Education

Bachelor's Degree

Tools

EDC systems

Clinical Data Management Systems

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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.

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.

Qualifications

• 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 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• 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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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.

What AbbVie Has to Offer

Our work can-and does-have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.