AbbVie ACPRU Data Systems Manager in Lake County, Illinois
ACPRU Data Systems Manager
USA, Illinois, Lake County
Research & Development
Ensure data collection systems for pharmacology and pharmacometric research trials conducted at the Abbvie CPPM Research Unit (ACPRU) meet all applicable regulatory and company requirements. Ensure data collection, review 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. Ensure all Data Systems staff activities, processes and resources support the successful conduct of clinical research at the Phase I Unit.
Responsiblefor compliance with applicable Corporate and Divisional Policies and procedures.
Manageall internal data management activities in support of clinical research studiesconducted at the ACPRU.
Ensureall draft clinical protocols are reviewed and comments are provided on aspectsof study design that impact study set up, datacollection and transmission, and workflow and implications forexternal client groups (sponsor/vendor).Offer suggestions for improvement.
Ensure clinical data collection and management systemsused by the ACPRU complywithall regulatory, SOP and protocol requirements.
Ensurequality and performance metrics are appropriate for assessment of CRU datasystems, metrics are captured in an accurate andtimely manner, are appropriately analyzed and corrective action (ifindicated) isincorporated into the ACPRU data systems to assurecontinued compliance with all relevant Company and Regulatory standards.
Manage cross-functional project teams. Allocate resources, set priorities for ACPRU Data Systems, prepare andpresent progress reports to management.
Collaborate with IT and other support personnel toensure accurate documentation,testing, validation and implementation of data management systems and processimprovements/upgrades.
Mentor,coach and train research staff on data management activities and processes,GCP, GCDMP and applicable regulations.
Level will be based on education & years of experience.
5years in Clinical Research
5years experience with Clinical research data systems
3years supervisory or leadership role in clinical research data systems or datamanagement
This individual must be able towork independently as well as in ateam environment and with all levels of personnel within the organization inorder to achieve the desired outcome with littleor no guidance. Mustbe able to make sound decisions based on situationat hand, understand when more information is needed in order to make a sounddecision, provide direction to clinic staff and assume responsibility for theoutcome of the decision.
This position requires a thorough knowledge of datamanagement and theability to apply that knowledge to a wide variety of situations and to proposepotential solutions to management and clients.
The job requires extensive knowledge of the researchand development of pharmaceuticals, all applicable regulations, GXP, GCDMP, and SOPsand a clear understanding of the effect of his/her decisions on the successfulconduct of clinical research studies and subsequent submission to regulatoryauthorities.
AbbVie is an Equal Employment Opportunity employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced