Clinical Compliance Manager I
- Employer
- AbbVie
- Location
- Lake County, IL, US
- Start date
- Sep 18, 2019
View more
- Discipline
- Clinical, Clinical Research, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest, Best Places to Work
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Job Details
- Responsible for compliance with applicable Corporate and Divisional policies and procedures.
- Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators
- Provides input on new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.
- Effectively communicates project progress/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues .
- Bachelor's degree (or equivalent ex-US) is required, typically in nursing or scientific field. An Associate's degree/R.N. (or equivalent ex-US)with relevant experience is acceptable.
- Must have 6+ years of Pharma-related/ clinical research related experience; 2+ years of experience preferably with clinical research, regulatory, compliance and/or quality control.
- Must have demonstrated a high level of core and technical competencies through management of various aspects of clinical trials (e.g., audits, study oversight, SOP development, quality assessments)
- Possesses good communication skills, demonstrated leadership abilities and problem solving skills.
- Demonstration of successful coaching/ mentoring in a matrix environment
- Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
- Preferred global exposure from study initiation through study completion in multiple phases of studies (Phase 1-3, 4) .
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
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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