• Independently manages and provides guidance and oversight for all components of clinical trials, from protocol/manual of procedures development and investigational new drug (IND) application submission, protocol implementation and study enrollment, to clinical study report and publication. • Proactively manages and leads a cross-functional study team, including risk identification and mitigation planning. • Recommends and implements innovative processes to improve and positively impact clinical trial management and deliverables. • Assist in the preparation of study protocol(s), informed consent documents, clinical study reports, clinical sections of IND applications, IND annual reports, etc. • Responsible for the development of study plans, manuals and study specific documentation including informed consent forms. • Performs study management and collaborates with site managers, data managers, statisticians, regulatory experts, pharmacovigilance team, site monitors, etc. • Coordinates other vendors involved in the trial such as central lab/biorepository, specialty laboratories, electronic Clinical Outcomes Assessment (eCOA) systems, electronic data capture systems (EDC) and interactive response technology vendor (IRT). • Acts as a cross functional liaison, communicating trial status and issues, to ensure trial plan aligns with program and client goals. • Escalates challenges appropriately to resolve issues related to study protocols or processes. • Responsible for creating and maintaining timelines, including aligning study start-up, enrollment projections, study conduct, and close-out activities with study and project goals, and using these timelines to track and manage trial progress. • Responsible for managing trial and vendor budgets, including review of invoices for accuracy. • Provides expertise in clinical site budget development and contracts for assigned clinical trials. • Works with Project Leadership and the site management team to identify and assess feasibility of potential clinical trial investigators and sites. • Develop trial-related training materials for study team members, external team members, and clinical staff. • May participate remotely or virtually in site initiation/training visits. • Works closely with the study team to develop trial associated clinical forms/data collection tools, including electronic case report forms and user acceptance testing, serious adverse event forms, etc. • Works with outsourced or in-house data management groups to create and implement study-specific tools to ensure clean data, e.g., metrics reports, patient profiles, etc. • Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participates in data reviews. • Responsible for oversight of study Trial Master File (TMF) for inspection readiness. • Collaborates with clinical quality staff to develop a quality plan, including audit readiness assessments for assigned clinical trials. • Participates in the recruitment and onboarding process for CTMs and other clinical operations team members. • Provides oversight and/or mentorship for less experienced staff. • May lead or contribute to development of program wide processes and initiatives; contributes to the development of standard operating procedures (SOPs), templates and forms and processes.