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Clinical Project Manager

Company: Aerotek
Location: Gaithersburg
Posted on: May 24, 2020

Job Description:

Our client is currently looking for a Clinical Project Manager who will be responsible for planning, implementation, coordination, reporting, and overall resource definition of their clinical trials. The CTM will ensure that clinical studies are completed according to the Protocol, Good Clinical Practice (GCP) guidelines, FDA Code of Federal Regulation (CFR), as well as our client's and/or the Contract Research Organizations (CRO) SOPs. The CTM ensures timely delivery and budget adherence in order for successfully study implementation and may supervise other clinical operations personnel. * Has responsibility for assigned Clinical Studies from an Operations perspective * Responsible for the direct oversight of all outsourced vendor partners/providers, i.e. CROs, Clinical Research Associates (CRAs), central laboratories, etc. * Responsible for organizing and delivering relevant Clinical Study training to other Clinical Operations/CRO staff * Achieves study objectives by working with cross-function team members to set project priorities and milestones and resolve project conflicts * Foster and develop a team approach to all activities associated with the implementation of clinical studies; the team includes CRO's Monitors/ CRAs, Clinical Operations Leads (COL's), etc. * Assesses the operational feasibility of studies and recommends execution and risk mitigation plans * Responsible for preparing detailed timelines and establishing clinical study milestones for assigned projects, and further ensuring timely delivery to include budget development and adherence. * Ensures appropriate clinical resources are available for the clinical project * Ensures GCP and regulatory compliance is maintained * Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc. * Maintains professional expertise through familiarity with therapeutic area and clinical research literature * Manages clinical projects from concept through clinical study report completion * Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts * Participates in meetings with investigative sites, key opinion leaders and consultants as needed * Contributes to the analysis, summary, and reporting of clinical data through the course of the study * Proactively identifies and resolves issues, and participates in process improvement initiatives as required * Responds promptly and appropriately to study questions and issues raised by senior management, investigative sites, vendors, monitors, and consultants * Reviews and approves invoices from study vendors, investigators, consultants, etc. * Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken; ensuring timely follow up and resolution * Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks * Maintains all study files, TMF and keeps team minutes and action items as necessary. * Conduct sponsor oversight visits; Co-monitors as needed * Performs other duties as assigned About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing -- Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Keywords: Aerotek, Washington DC , Clinical Project Manager, Executive , Gaithersburg, DC

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