Clinical Project Manager

Duration & Type: Full Time position with a CRO client Location: Remote at present, eventually in Rockville, Maryland or a mutually agreed upon regional location Responsibilities: • Provides leadership, direction, and management on all aspects of assigned global clinical projects and leads a cross-functional team to manage the study to ensure quality deliverables; • Manages assigned project and related activities, including timelines, deliverables, study budget as well as site/vendor budgets, contracts, and payments; • Acts as a principal liaison between the sponsor, investigative sites, and other study personnel and service providers; identifies any potential issues and develops mitigation plan and escalates as appropriate; • Reviews site visit reports, protocols, clinical study reports, and any other study-related documents; • Participates in the design and review of clinical protocols, case report forms (CRFs/eCRFs), associated study documents, monitoring plans, and regulatory submissions and reports in collaboration with clinical project team; as well as prepares, study-specific SOPs and quality management plans and communicates them to the team; • Plans, coordinates and conducts investigator meetings, kick-off meetings, therapeutic training of CRA’s, and project-specific training of CRAs; and Data Monitoring Committee (DMC) meetings, if indicated; • Conducts weekly/bi-weekly teleconferences with the sponsor, sites, and vendors; prepares agenda, provides project status updates, and reviews and finalizes minutes of the teleconferences; and tracks study progress and disseminates information to project team members; • Oversees clinical investigational site training on protocol amendment(s), adverse event reporting, ensuring accurate and verifiable data, resolving queries, ensuring drug accountability, reviewing site study files, and ensuring the integrity of clinical data, etc.; • Manages study budgets and provides monthly invoices and other information to Budgets and Contracts/Finance department within the specified timelines; • Utilizes tact and experience-based knowledge to resolve problems (clients or staff), explaining specific policies while representing the Company in a professional manner and maintain positive client relations; • Ensures adherence to study specific SOPs, ICH Good Clinical Practice, and FDA regulations; • Performs other Clinical Operations and/or administrative duties as assigned by the Director of Clinical Operations • Must be available for after-hours calls; Required: • Education: College degree or higher in health care, a scientific field and/or in a field directly related to this position. 5 -7 years of directly related experience may be substituted for a college degree. • Experience in Therapeutic Area: Burn, SCI, Critical Care, CNS preferred For consideration, please send resume to [email protected] Apply tot his job