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ACPRU Data Systems Manager

Employer
AbbVie
Location
Lake County, IL, US
Start date
Apr 10, 2019

View more

Discipline
Clinical, Clinical Data, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

Purpose:
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.

Responsibilities:

 

 

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedure s .
  • Manage all internal data management activities in support of clinical research studies conducted at the ACPRU.
  • Ensure all draft clinical protocols are reviewed and comments are provided on aspects of study design that impact study set up, data collection and transmission, an d workflow and implications for external client groups (sponsor/vendor). Offer suggestions for improvement.
  • Ensure clinical data collection and management systems used by the ACPRU comply with all regulatory, SOP and protocol requirements.
  • E nsure quality and performance metrics are appropriate for assessment of CRU data systems, metrics are captured in an accurate and timely manner, are appropriately analyzed and corrective action (if indicated) is incorporated into the ACPRU data systems to assure continued compliance with all relevant Company and Regulatory standards.
  • Manage cross-functional project teams. Allocate resources, set priorities fo r ACPRU Data Systems, prepare and present progress reports to management.
  • Collaborate with IT and other support personnel to ensure accurate documentation , testing, validation and implementation of data management systems and process improvement s /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.

Basic:

 

 

 

 

  • Bachelor's Degree
  • 5 years in Clinical Research
  • 5 years experience with Clinical research data systems
  • 3 years supervisory or leadership role in clinical research data systems or data management
  • PIMS 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 in order 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 in order to make a sound decision, provide direction to clinic staff and assume responsibility for the outcome of the decision.
  • This position requires a thorough knowledge of data management an d 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 developmen t 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.

 

 

Company

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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