at AbbVie in North Chicago, Illinois, United States
Job Description
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose:
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. Assist the DS Section Manager (DSSM) in directing Data Systems (DS) staff activities, processes, and resources to ensure the successful conduct of clinical research at the ACPRU.
Responsibilities:
+ Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
+ At the direction of the DSSM, assist in the management of all internal data management activities in support of clinical research studies conducted at the ACPRU.
+ 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.
+ At the direction of the DSSM, allocate DS resources, set DS priorities, prepare and present progress reports to management.
+ 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
This position will be required to sit on-site 3 days / week
Qualifications:
+ Bachelor’s Degree
+ 4 years in Clinical Research
+ 4 years’ experience with clinical research data systems
+ 1-2 year supervisory or leadership role in clinical research data systems or data management
+ 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, provide direction to DS staff 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 extensive 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: ?
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+ 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. ?
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Note: No amount of pay is a 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 employee 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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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