Clinical Research

• Serves as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery of clinical studies.
• Supports and guides Clinical Trial Managers and Clinical Project Assistants ensuring alignment of study activities, promoting best practices, and driving a unified approach to achieve study objectives.
• Acts as the primary point of contact for internal cross functional teams.
• Leads site management and performance oversight, including ensuring proper training, fostering strong site relationships, and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements.
• Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out.
• Develops study related plans and documents, including informed consent forms, ensuring alignment with study objectives, regulatory requirements, and overall study strategy.
• Collaborates on site identification and selection.
• Participates in EDC set-up by contributing to case report form design, user acceptance testing, development of completion guidelines, and other related activities, supporting study requirements and data quality.
• Oversees clinical data entry progress ensuring timely resolution of incomplete data and outstanding queries.
• Contributes to the development and management of site budgets and ensures timely and accurate invoice payments in accordance with site payment terms.
• Partners with cross functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks to ensure successful execution.
• Provides oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely study execution while proactively addressing risk and performance issues.
• Facilitate external communication with site staff and pharmaceutical partners (as applicable).
• Ensures electronic Trial Master File (eTMF) is current and maintained.

Senior Clinical Trial Manager

Clinical Research Coordinator I – Non RN

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