Marna Grim Email & Phone Number

• Works in direct partnership with Clinical Development and closely with key stakeholders in Quality, Clinical Laboratory, Regulatory A ffairs, IT/Software and other functions to evaluate, design and implement consistent.
• Drives the creation, deployment, and management of Clinical Operations systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities
• Trains and guides Clinical Development team on inspection readiness needs, activities, timeline, and processes
• Oversees the development, deployment, and update of fit-for-purpose SOPs in accordance with applicable guidelines and company policies
• Supports evaluation and selection of new clinical operations’ systems in collaboration with Clinical Leadership and other required key stakeholder or functions
• Support Clinical Development study teams in achieving and maintaining audit readiness

Supports development and implementation of a Clinical Development Operations infrastructure strategy to enable optimized planning and execution of Chinook’s clinical trials. Partners across functions to lead clinical process development and implementation, driving fit-for-purpose improvements, guiding procedural change management, and conducting periodic.

* Initiated inspection readiness activities for four clinical studies, leveraging cross-functional teams to ensure eTMF completeness, storyboard development, and team preparation.* Embedded into clinical trial teams; provided ongoing GCP guidance to ensure compliance and minimize risk; ensured potential risks and deviations were documented, reported, and.

Successfully established and provided oversight of client-dedicated teams and processes. Managed up to 25 geographically-distributed staff in accordance with organization’s policies and laws. Planned, assigned and directed work of employees; appraised performance and guided professional development; rewarded and disciplined employees; addressed employee.

Directed projects and resources, ensuring quality deliverables to customers. Managed personnel issues and conflict management and defined staff expectations.* Set and implemented site- and team-specific objectives to ensure staff had a consistent understanding and positive impression of strategy for regional and global objectives.* Used strong.

Managed the local Regulatory Affairs team. Assigned staff to projects and ensured completion according to timelines and budgets. Site representative to company’s North American Regulatory team.

• Plan, resource, and manage publishing of regulatory documents and submissions.
• Participate on cross-site publishing team.
• Participate in system validation as necessary.
• Provide training and supervision of publishing processes.
• Provide regulatory review of regulatory submissions.
• Act as interface between both internal and external clients.

Planned, resourced, and managed publishing of regulatory reports, documents and submissions. Trained and supervised staff on publishing processes and requirements. Contributed to a cross-site publishing team in order to implement and validate best practices across the organization.

Scheduled and organized workflow of department.Supervised, scheduled, and trained Desktop Publishing Specialists.QC work of Desktop Publishing Specialists.Managed production of new books, annual and updatable, from initial concept and design to printing.Led team for semiannual updates of flagship products of company, including scheduling, technical.

Education record

Journalism/Pr