Ryan Gately Email & Phone Number

Cambridge, Massachusetts, United States

Manage and ensure oversight of the Drug Supply requirements for out-sourced and internal preclinical scientific research to ensure study execution.Fulfill Drug Supply needs through acting as the interface between the Scientific Project Team, Operational Experts, Scientific Monitors, Compound Supply, Shipping & Compliance, and external collaborative research partners.Liaise with a team of researchers (Therapeutic Area Heads, Project Team Members, Research Colleagues and Study Monitors) to obtain requested study information.Calculate test article quantities of drug substances for toxicological studies.Order and track drug substances, compounds, excipients and other chemicals for preclinical studies.Inquire and provide documents and safety information of test articles (Certificate of Analysis, Analysis Reports, Legacy Data Sheets, Safety Data Sheets, Protein Reports, etc.) to support studies, assays and analysis.Request shelf life ex-tension of test articles on behalf of Study Monitors for preclinical studies.Coordinate the transportation of test articles at test facilities to enable timely study initiation.Provide transparency and tracking of Drug Supply support to stakeholders and management.

Cambridge, Massachusetts, United States

Responsible for the preservation, retention, and lifecycle management of scientific and business records to comply with legal regulations and internal retention policies.Drove e-data archiving process to complete the transfer of data with GxP validated tools, to assure that archived data is stored in secure locations.Participated in the creation and review of Stand Operating Procedures to align the policies of the global records management group.Maintained business continuity and disaster recovery plans for the records management department on an annual basis, ensuring the protection of company assets in the event of a disaster.Negotiated contracts and prices with service providers in imaging projects, storage accounts, microfilming, and other business needs.Performed annual audits of third-party vendors to ensure the storage of scientific samples and company business records met quality control guidelines and standards.Lead lab heads, scientists, and group leaders with compliant archiving guidance to ensure data integrity with storage and retrieval processes for record compliance.Assisted as a cross functional stakeholder in merger, acquisition, divestiture, and closure activities to support mitigation by ensuring the organization, security and data integrity of records and information.Collaborated with IT to develop information repositories to ensuring the organization, security and integrity of electronic data and records.Improved archiving response time by 60% through creation of online archive reporting process.Updated the global monitoring of data review process by formulating key metrics on records.Assisted Operational Compliance in planning and registration of Human Tissue Samples to facilitate compliance. Ensured biological samples comply with data privacy rules, and register tissue in a primary registration system.Assisted Controlled Substance Program by registering Prescription items/Controlled substances into an electronic tracking tool.