• supports late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities • Working collaboratively with the study team and clinical leadership • focuses on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data • Support set up and execution of late phase clinical trials with a focus on data quality • Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity • Provide input into and implementation of data management plan, CRF design, and data review oversight • Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission • Assists Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects • Anticipate and actively manage problems across a broad spectrum of cross-functional teams • Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents • Support appropriate training, recruitment, and development requirements for matrix team resources.