Clinical Process and Procedure Manager in Lake Forest, IL

• Manager is looking for someone with a compliance background that would include some auditing experience and document quality review.
• For documents that are not compliant with policy and procedures, this individual would be responsible for following up with the functional area to provide direction on how to remediate the issues.
• We're looking for someone who can work 36-40 hrs/week.
• Tasks may include, but not limited to: detailed review of documentation to ensure compliance with SOPs, following up on any deviations, creating and maintaining metrics, responding to urgent requests from upper management, preparation of slide decks.
• The candidate will be responsible for supporting specific teams in regards to their compliance of SOPs.
• The ideal candidate will have auditing experience and be very detailed.
• Prefer experience working in the pharmaceutical industry.
• Must be a fast learner that will take responsibility for their development in understanding the business environment.
• This individual would be responsible for learning, understanding, and applying all policy and procedure requirements for scientific publications and using this knowledge to ensure scientific publication documents from various functional areas are compliant.
• Candidate should be comfortable in situations in which they need to discuss and defend their reasoning on why there is non-compliance. (no managerial responsibilities, however)
• Management of the development, maintenance and implementation of process, procedures, tools, templates, etc., used in GPRD clinical research worldwide.
• Management of multiple complex projects aimed to support the development and implementation of standardized processes and procedures needed as a result of the organization, industry practices change and regulations change.
• Provide subject matter expert consulting support in development of training, tools and templates, and provide technical interpretative guidance to the worldwide clinical research community.
• Active participation and/or leading of global compliance-based initiatives.
• Technical writing for document/process development.
• Communication of project/initiative related information at management meetings and presentations.
• Responsible for coordination of activities across cross-functional areas for the completion of projects and process improvement compliance related initiatives.

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