Manager, Standards & Compliance II

Employer
AbbVie
Location
Lake County, IL, US
Posted
Jul 31, 2018
Ref
1805474
Required Education
Bachelors Degree
Position Type
Full time
Manager responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trial(s); including managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics.

Will have direct reports and will matrix manage with assigned therapeutic area or functional partners to ensure proper documentation of AbbVie procedures, implementation of process changes, ensure compliance and/or execution on timelines and quality deliverables.

Is aware of both internal and external business environments, assesses impact on the processes for clinical study execution and makes modification as necessary.

Interprets relevant regulations and guidelines and act as a SME for Clinical Operations. Assist clinical teams with inspections, audit responses and consult on root cause analysis, as required.

Independently takes initiative to resolve problems and mitigate risk. Escalate significant issues to management.

Key Responsibilities Include :

  • 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 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.


POSITION MAY BE FILLED AT LEVEL COMMENSURATE WITH EXPERIENCE

Basic:

  • 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 7+ years of Pharma-related/ clinical research related experience; 3+ 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 and demonstrated leadership abilities and problem solving skills.
  • Demonstration of successful coaching/ mentoring in a matrix environment; direct people management preferred
  • Considered a Subject Matter Expert and competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
  • Experience with global studies from initiation through study completion/primary data analysis and/or in multiple phases of studies (Phase 1-3, 4)