Argenta

• Coordinates and conducts GCP and study protocol training at study sites and assures training is documented • Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities • Assists in reviewing the study records and all study notebooks to ensure contents are current and complete • Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits • Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies • Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol • Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation • Serves as the liaison between Argenta US Clinical and study site personnel • Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel • Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor • Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel • Builds relationships with key individuals and contributors in the organization and beyond

• Obtains a clear understanding of all aspects of the study and defines roles of study personnel • Collaborates with the sponsor to establish projected study timelines for the study • Provides detailed oversight to ensure tasks are completed correctly and on time

• Facilitates and supports the regulatory and drug development requirements of external clients and internal projects • Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications • Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges • Creates regulatory solutions to complex issues • Provides client accurate expert regulatory advice on animal health product development • Represent Argenta in industry associations (e.g. GADA, AHI, SQA) • Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications

• Supports the Americas CRO business (regulatory to pre-clinical to clinical service) needs of Argenta Molecule to Market, and Risk/Mitigation plans • Effectively manage the product development requirements (pre-clinical and clinical projects) of internal and external projects • Demonstrates an awareness of current regulations, guidance's, and the animal drug development process, while maintaining a flexible and creative mindset to work through product development challenges. • Contribute to the development of business strategies to increase profitability and grow the business to create value. • Manage development projects or key development project areas from initial conversations to live-phase study activities to close-out / final study report signatures to tracking overall timelines and budgets for study activities. • Coordinates selection of the vendor(s) for study protocol conduct &/or laboratory requirements and activities including the provision of necessary supplies required by the study protocol • Provides oversight to ensure tasks are completed correctly and on time (i.e. oversight in the tracking of adverse events (AEs) encountered in the study and ensures that all serious AEs and non-serious AEs are communicated appropriately to the Sponsor) • Coordinates the creation of materials and documentation for the study, and QA resources, as required • Directs and provides oversight of investigational veterinary product/control product inventory, accountability, labelling, regulatory documentation/notifications, and shipment of drug supplies to/from the Sponsor and study sites