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 Clinical Development policies and procedures governing the conduct of clinical trials, including the integration of systems such as EDC, CTMS, eTMF, and Document Control, to improve operational excellence and e fficiency while driving agility and time to market. Lead in ensuring… Show more 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 Clinical Development policies and procedures governing the conduct of clinical trials, including the integration of systems such as EDC, CTMS, eTMF, and Document Control, to improve operational excellence and e fficiency while driving agility and time to market. Lead in ensuring that Clinical Development is prepared for internal and external audits and partners with Quality and other functions to resolve audit findings.● 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● Be a subject matter expert and Thought Leader within Clinical Development regardingregulations governing clinical trials● Drive training activities, including tracking compliance, training matrix development,preparation of training materials, conducting training and competency assessments asneeded● Actively participates as a member of the Clinical Development Leadership Team in thedevelopment and execution of department organizational initiatives, goals, and strategies; quality and process initiatives. Includes the identification of process challenges, process enhancements, and training Show less

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 quality checks against documented procedures. Supports staff onboarding and inspection readiness, and contributes to other GxP initiatives and… Show more 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 quality checks against documented procedures. Supports staff onboarding and inspection readiness, and contributes to other GxP initiatives and activities.Accomplishments include:* Expanded clinical operations infrastructure with fit-for-purpose SOPs, guidance documents, templates, and forms to allow consistent, compliant delivery.* Coordinated and led regular cross-functional process review meetings.* Implemented centralized informed consent and essential regulatory package review and approval process.* Co-led CDO inspection readiness team, driving BIMO workstream.* Proposed and led process of including study-specific training management in the LMS.* Managed SOP training requirements, matrix, and metrics for CDO.* Represented and advocated for CDO on team for eTMF, eQMS, and eLMS implementation.* Initiated and managed deviations and CAPAs.* Employed change management methodologies, including proactively planning, preparing for, socializing, and initiating activities in anticipation of key changes, anticipating needs for training and discussions well ahead of implementation, during and after changes are made.* Maintained awareness of regulatory and industry changes particularly related to ICH GCP, GCP related aspects of the Code of Federal Regulations, and relevant global regulatory requirements; apply them as appropriate to process improvements.* Conducted ongoing and proactive risk identification and mitigation.* Implemented, generated, monitored, and reported on key performance metrics.* Led development of internal team SharePoint site.* Encouraged creative, efficient, and scalable solutions. Show less

* 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 escalated as necessary. * Served as internal GCP consultant to study teams in both the US and the UK. Determined organization-wide… Show more * 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 escalated as necessary. * Served as internal GCP consultant to study teams in both the US and the UK. Determined organization-wide training needs and oversaw GCP fundamental and refresher training.* Planned, implemented, managed, and updated Standard Operating Procedures (SOPs), processes, communication, and infrastructure for Clinical Compliance and Clinical Operations.* Reviewed protocol deviations to determine categorization, significance, and reportability.* Performed compliance review and approval of clinical trial materials including Clinical Protocol, Risk Management Plan, TMF Plan, Informed Consent, etc.* Developed annual GCP audit plan, including risk-based selection and scheduling of site audits. Assisted functional teams in constructing robust CAPAs and audit responses. Participated in site and vendor audits.* Led departmental initiatives aimed at innovation, process improvement, and efficiency. Assisted in identification of process gaps or areas of process improvement to find efficient and scalable solutions. Show less

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 relations issues. * Cooperated with clients to ensure operational efficiency and quality; implemented periodic revisions to processes to… Show more 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 relations issues. * Cooperated with clients to ensure operational efficiency and quality; implemented periodic revisions to processes to ensure maximum efficiency and customer satisfaction.* Created Informed Consent and Essential Document Packet Review teams for North America in order to provide optimal quality to customers. Developed processes, documentation, training materials, and guidance information for internal customers.* Remotely managed the selection and onboarding process for new employees which contributed to 90%+ employee retention and success rate.* Created strategic initiatives and developed implementation plans, including metrics measuring quality and timelines.* Managed successful offshoring of EDP Review work which lowered costs. Provided training and expertise to staff in Slovakia and India.* Directed team participation in both internal and customer audits; provided recommendations and requirements to Corrective Action Plans as needed based on audit findings.* Determined operational strategy and/or expectations and parameters for key deliverables, in conjunction with management team colleagues.* Reviewed and analyzed performance metrics and processes.* Merged regulatory review and study startup functions, eliminating handoffs. Provided cross-functional training and supervision of multiple roles (regulatory / Informed Consent Form review, startup specialists, contract negotiators, and RSU leads).* Accountable for employee departmental efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines. Show less

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 relationships with managers of other functional groups to gain cooperation and streamline processes.* Wrote/revised departmental SOPs and… Show more 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 relationships with managers of other functional groups to gain cooperation and streamline processes.* Wrote/revised departmental SOPs and work instructions to provide clear and direct guidance on processes, in order to produce higher quality and limit re-work. Reviewed and contributed to SOPs owned by other departments.* Defined goals that increased knowledge and skills of staff. Show less

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 editing, layouts by composition house, and printing within extremely tight deadlines.Reengineered process to cut schedule by… Show more 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 editing, layouts by composition house, and printing within extremely tight deadlines.Reengineered process to cut schedule by one-third, enabling company to beat competitors to market for two successive years.Produced 22 books annually from manuscript to final layout, ensuring quality control.Participated in web site development team.Prepared books for printer as required.Designed/revised book covers as needed. Show less

Education record

Journalism/Pr