Responsible for the operational planning and execution of multiple Phase II - III global/international studies, according to ICH-GCP and required regional regulations as applicable from protocol concept through the clinical study report. Ensures completion of study deliverables; develops Therapeutic Areas knowledge and expertise through internal training and external conference attendance. Responsible for the overall management of assigned study conduct, including oversight of the CRO and Trial Project Leaders.
PRIMARY DUTIES AND RESPONSIBILITIES:
Manage full scope of study conduct in collaboration with Administrative Operations to ensure studies are conducted according to the Code of federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and WU SOPs.
Collaborates with all relevant groups (Trial pharmaceutical partners, Project Arm Leaders, Administrative and Clinical Operations, Cores/Components, CRO, vendors, performance sites) to develop and manage clinical project timelines.
Coordinates meetings with study team members as appropriate for the project.
Disseminates clinical project communication to all functional groups as appropriate.
Contributes to protocol synopsis development and Clinical Operations feasibility assessments.
Writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with trial pharmaceutical partners, Project Arm Leaders and Clinical Operations.
Participation in the selection of CRO and all clinical vendors and cores/components (biomarkers, imaging, data management) for assigned studies.
Provides oversight of vendors/subcontracts (biomarkers, imaging, data management) which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
Identify resource issues and escalate to DIAN-TU PI/Director, Deputy Director, Clinical Operations Director and/or Administrative Director.
Planning and participation in investigator meetings in collaboration with all cross-functional team members.
Ensure training of Project Arm Leaders, CRO, vendors, all performance sites and DIAN-TU Cores/Components on the protocol and expectations of the study.
Responsible for identifying vendor, CRO, performance site, Project Leader, and/or collaborator issues and bringing to the attention of the DIAN-TU PI/Director, Deputy Director, Medical Director, Clinical Operations Director and/or Administrative Director for discussion.
Provides input to problem-solving and implements corrective action plan when necessary.
Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO, where applicable, to resolve performance site issues.
Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO and/or vendors (biomarkers, imaging, data management) for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations.
Manages timelines and maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested.
Collaborate with pharmaceutical partners to ensure appropriate and timely drug supply for assigned studies.
Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
Review and input to Clinical Study Report.
Bachelor's degree required.
Minimum of 5+ years’ experience in clinical research and program management including leadership and management experience.
Telecommuting is allowed.
Internal Number: 48025
About Washington University
Washington University School of Medicine is committed to advancing human health throughout the world. As noted leaders in patient care, research and education, our outstanding faculty has contributed many discoveries and innovations to science and medicine since the school’s founding in 1891.
Located on the Washington University Medical Campus adjacent to the Cortex Innovation Community, we are one of seven schools of Washington University in St. Louis.
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