Randstad Clinical Project Manager in North Chicago, Illinois
Clinical Project Manager
location:North Chicago, IL
salary:$25 - $30.91 per hour
date posted:Wednesday, February 6, 2019
industry:Professional, Scientific, and Technical Services
Clinical Project Manager
Person is responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trail(s); included managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics. Will matrix manage with as signed therapeutic area or functional partners to ensure proper documentation of Company 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 assists in making modiciaton as necessary.
Develops initial interpretation of relevant regulations and guidelines initiative to resolve problems and mitigate risk.
location: North Chicago, Illinois
job type: Contract
salary: $25.00 - 30.91 per hour
work hours: 9 to 5
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/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions of solutions to manage the issues.
GCP exception management in partnership with the business:
Issue Escalations for potential significant non-compliance
Provide consultation on ad-hoc compliance questions
Bachelors degree (or equivalent ) is required, typical in nursing or scientific field. An Associates degree/R.N. 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 aspect of clinical trails (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 (Phases 1-3, 4).
skills: SOP, Quality Assurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.