\nThe Clinical Trials Manager, Clinical Operations role provides site level management at the trial level and may be assigned as a lead on a clinical trial, with oversight by the Director, Clinical Operations within the organization. The Clinical Trials Manager supports the Clinical Trial Lead on global studies in both trial operations and site management oversight and may serve as the operations lead on Early Phase studies, with oversight by the Director of Clinical Operations.  The role provides operational oversight at the site level and country level (for larger global trials) ensuring successful cross-functional delivery of clinical trial, within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The Clinical Trials Manager may be accountable for the trial level oversight of some external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol synopsis to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.\n\nThe Clinical Trials Manager role will assist in the development and review of Clinical Operations Department SOPs, Plans and System build.  In addition, will lead process improvement initiates, create processes not currently in place, including the creation of site/trial management tools.  For outsourced trials to a CRO, this role will serve as a key liaison with oversight of the monitoring group.\n\n \n\nResponsibilities: \n\n\n* Lead operational aspects of assigned clinical trial(s), project team, and outsourced CRO/Vendors with oversight by the Director of Clinical Operations\n\n* Collaborate with the clinical trial lead to coordinate all aspects of site level management when assigned to a large global clinical trial\n\n* Work with CRO/Vendor partners to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed\n\n* Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with CRO/Vendors\n\n* Maintain therapeutic knowledge and familiarity with clinical protocol(s) and project(s) as appropriate\n\n* Work with CRO/Vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met\n\n* Oversee monitoring activities by reviewing visit reports and protocol deviations\n\n* Oversight of CRO monitoring team activities and deliverables\n\n* Attend site visits as a co-monitor and quality check, as necessary, when outsourced to a CRO\n\n* May be assigned a trial site to monitor as necessary\n\n* Review and contribute to study protocols, changes in eCRF design, laboratory manuals, monitoring guidelines, pharmacy manuals, informed consent forms, and other study-related documents\n\n* As operational lead for an Early phase trial, perform financial management, including review and approval of site contracts and budgets, as well as CRO/Vendor invoices with oversight by the Director of Clinical Operations\n\n* Assist in tracking and coordination of trial related materials, including; investigational product, clinical trial and laboratory samples\n\n* Organize and manage site round-table meetings and site recruitment meetings\n\n* Participate in the development, review and implementation of departmental SOPs, systems and processes\n\n* Assist in preparation and review of documents including Informed consent templates, monitoring guidelines, site guidance manuals, laboratory manuals, study plans and other study related documents as requested\n\n* Provides oversight of external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines\n\n* When acting as an Early Phase trial lead, provide trial level leadership of the cross-functional team to ensure the trial is operationalized in compliance with health authority regulations and guidelines and internal operating procedures and processes\n\n* Ensures that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial utilizing the available tools\n\n* Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Clinician, ensures appropriate trial-specific training is given to Trial Team members and/or to the CRO\n\n\n\n\n \n\n \n\nRequirements: \n\n\n* BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)\n\n\n* Minimum of 4 years clinical trial experience in the pharmaceutical industry or CRO \n\n\n\n\n\n* Experience with managing Early Phase trials or prior experience in a senior CRA role, ideally in the psychiatric space\n\n* Willingness and ability to travel up to 20% of the time, defined by business needs\n\n* This position requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment\n\n* Requires clinical research operational knowledge, project planning/management, communication, and presentation skills. Must have the ability to manage all aspects of execution of a clinical trial. Experience managing teams in a virtual environment is required\n\n* Experience in vendor management strongly preferred\n\n* Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness\n\n\n \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Senior and Senior jobs that are similar:\n\n $40,000 — $80,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nDurham, North Carolina, United States