Analyst, Data Systems

ABBVIE; North Chicago (IL); On-site; USD 66,000 - 126,000; Full time

Benefits offered by this job

Benefits package

401(k)

Paid time off

Job summary

AbbVie in North Chicago, IL is seeking a Clinical Data Manager to support the conduct of clinical research trials in compliance with regulatory and company requirements. You will ensure data collection and transmission systems meet the needs of investigators, staff, and sponsors.

The role includes designing data collection systems reflecting protocols, maintaining data quality, and mentoring staff on GCP, GCDMP, and SOPs. A Bachelor’s degree and several years in clinical research are required.

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.
• Must understand GXP, GCDMP, and SOPs; able to work independently and in a team.

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 study setup, data collection and transmission, and workflow and implications for external client groups (Sponsor/vendor).
• 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.

Skills

Clinical Research

Data Management

Leadership

GCP

Education

Bachelor’s Degree

Tools

Electronic Source Systems

Job description

• Compensation: USD 65500 - USD 125500 - yearly

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 ,X andYouTube.

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 orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this roleat thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on manyfactors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount isearned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat areallocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolutediscretion, consistent withapplicable 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.