Randstad Clinical Project Manager in North Chicago, Illinois

Clinical Project Manager

job details:

  • location:North Chicago, IL

  • salary:$25 - $30.91 per hour

  • date posted:Wednesday, February 6, 2019

  • experience:7 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:27712

job description

Clinical Project Manager

job summary:

  • 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

education: Bachelors

responsibilities:

  • 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:

  • Nonconformities

  • Potential nonconformity

  • Planned deviations

  • Issue Escalations for potential significant non-compliance

  • Inspection support

  • Provide consultation on ad-hoc compliance questions

qualifications:

  • 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.