Job Summary:

Clinical Project Manager (CPM) is key to the success of the overall conduct of a clinical trial from planning to final report. CPM will assist in all areas of conducting a clinical research program and maybe responsible for the conduct of specific aspects of a clinical program including but not limited to: developing the clinical trial strategy, timelines, forecasting, managing the overall study budget, developing risk management / contingency plans for minimizing impact on project objectives, site selection and management, monitoring, coordination of clinical data management, data analysis functions, and CRO and Vendor selection and management.

Job Details:

Support the development of project related deliverables including the project management plan, overall clinical budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc.
Responsible to develop of study related documents, including protocol, informed consent, IB, regulatory binder, training materials, etc. and provide input to case report forms.
Responsible to manage and track the overall study budget, track and administer payments, and provide financial updates.
Responsible for the proactive management and conduct of clinical trials. Provide centralized site support, communication and coordination to assure timely completion of start-up, enrollment and all other study activities.
Assist in the review site visit reports and enrollment progress and monitors the study for protocol, federal, and local compliance.
Support vendor selection process, including RFP to contract and change order process for CROs and other external service providers (ESP). Provide day to day management of ESPs ensuring quality deliverables and adherence to the scope of work;
Manage clinical supply shipments and inventory.
Ensure compliance with Terumo policy, procedures and SOPs, GCP, and local, regional and federal regulations.
Provide periodic updates, reports, etc. as requested. Manage ongoing communication of operation issues and provides progress reports to the study team.
Assist with Database freeze, Database lock, annual progress reports, and final clinical study reports.
Responsible for Site Management and Monitoring as required.
Other duties and responsibilities as assigned.

Position Requirements:

Knowledge Skills and Abilities
Knowledgeable in all facets of clinical operations including ICH / GCP, 21CFR 50/54/56/812/814 for the conduct of clinical research studies.
Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
Effective analytical and problem-solving skills.
Demonstrated project management skills across various aspects of clinical research project.
Ability to work in a highly matrixed team environment.
Ability to adapt to changing priorities.
Proficiency with Microsoft Suite (e.g. Outlook, Project, Visio, Excel, Word etc.) and various data management systems / EDC systems.
Demonstrated successful site management and monitoring.
Ability to travel consistent with project needs.

Background Experience
Bachelor’s degree in a clinical or scientific discipline and minimum of 5 years’ clinical research experience; or equivalent combination of education, training and work experience.
Must have at least 2 years of clinical trial / clinical research site management, monitoring and project management / lead experience.
Medical device industry experience strongly preferred.
Direct experience with site and / or sponsor level audits or FDA BIMO investigation(s) preferred.

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