Ryan Walter Email & Phone Number

Boston, Massachusetts, United States

Deerfield, Illinois, United States

Deerfield, Il

Leadership of Alliance partner, cross functional team, with oversight of strategic partner CRO and supporting global vendors to ensure study objectives, milestones, budget and timelines are met for complex phase III CNS trial. Responsible for providing study level updates, risks and solutions, including timelines and budget, to clinical program team and Alliance joint clinical management. Responsible for the planning and management of global study budget, and negotiation of vendor and site contracts. Leads cross functional development, writing, review and approval of critical study documents (protocol, ICFs, study plans, site communications and guides). Represent Clinical Operations oversight for medical monitoring issue review and management. Partner with senior management to develop, plan and execute CNS-focused operational strategy meetings, providing content and study management trends and topics for CNS trial colleagues. Provide lessons learned experiences and guidance through presentations for global colleagues in clinical operations forums and meetings. Act as experienced consultant to global clinical operation process development for FDA and MHRA Inspection Readiness initiative.Responsible, as subject matter expert, to manage global standard operating procedure for duplicate subject tracking, with accompanying cross functional global training, and management of clinical operations process execution.

Deerfield, Il

Responsible for complex Phase III CNS trial planning, development and management, with specific execution for the US region. Responsibilities included Alliance management and partnership, oversight and management of strategic partner CRO and 9 supporting vendors. Led cross functional development, writing, review and approval of critical study documents (protocol, ICFs, study plans, site communications and guides). Successfully managed global study budget, site selection, including negotiating site and vendor contracts, development and execution of site meetings (investigator meetings, cognitive assessment training, site forums) and study metrics creation for senior management reporting. Led startup of phase III extension study to successfully meet start up timelines and study goals through management of vendor selection and start up, protocol design and writing, vendor and site contract execution, and cross functional study document creation. Partnered with senior management to develop, plan and execute CNS-focused operational strategy meetings, providing content and study management trends and topics for CNS trial colleagues. Partnered with Clinical Science to develop and champion in-house duplicate subject tracking tool and educational materials for cross functional training and execution. Led cross functional team, as subject matter expert, to expand duplicate subject tracking concept by developing and authoring global standard operating procedure, with accompanying cross functional global training, and selection and piloting of 3rd party vendors.

Deerfield, Il

Responsible for budget, vendor oversight and management of Phase III clinical trial during close out phase. Responsible for review of critical regulatory documents (protocol, ICF) for content and adherence to ICH and government regulations. Participated in cross functional development, review and testing of case report forms, data management checks, study manuals and site tools.

Chicago, Il

Responsible for management and site monitoring team during varying study cycles (maintenance, close out) of observational, Phase IV, Phase III clinical trials, including management of protocol procedures, site training, EDC users and training, deviations, IP accountability, regulatory critical document review, site and vendor contract review and remote monitoring for 83 sites across 6 various therapeutic area protocols. Coordinated study monitoring through management of monitor schedule, preparation of visit agendas, trip report review and follow up letters. Supported development of project-related and training materials, such as site management plans, ICFs, EDC completion guidelines, protocol training slides, critical document checklists, reports and newsletters. Assisted in study financial review and reporting.

Sacramento, Ca

Responsible for the coordination of over 250 active research subjects for a National Institute of Mental Health funded research study through effective management of behavioral and neuroimaging protocol evaluating cognitive abilities in patients experiencing their first break of psychosis. Conducted multiple clinical interview batteries evaluating psychopathology in patients with Schizophrenia and Bipolar disorder. Administered, processed and analyzed cognitive test batteries and complex neuroimaging paradigms evaluating psychiatric patients. Designed, coded, administered, analyzed and presented at scientific conferences independent fMRI research exploring cognitive control in healthy subjects. Assisted in preparation and writing of published scientific manuscripts, posters and presentations. Assisted in hiring and training of new staff in research methodology, clinical assessment interviewing, cognitive battery, and neuroimaging administration. Trained and advised staff and collaborators on scripting software and design paradigms for psychological data collection.

Pittsburgh, Pa

Coordinated cognitive testing paradigms for neuroimaging project evaluating cognitive dysfunction in patients experiencing psychosis while undergoing cognitive rehabilitation therapy. Responsibilities included patient recruitment, administration, design and coding of cognitive behavioral and neuroimaging tasks, neuroimaging data analysis and neuroanatomical region of interest drawing tools.