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ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
Acting as Protocol Lead on one or more clinical trials and serving as the main point of contact for clinical site management and clinical trial site monitoring functions
Participating as a member on assigned cross functional study team
Assisting with the design and review of clinical trial protocols, informed consent, case report forms (CRFs), Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups. Participating in the Clinical Protocol Committee as appropriate.
Creating and maintaining clinical trial start-up documents such as the Clinical Monitoring Plan. Developing or providing clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate.
Leading identification, evaluation and selection of clinical trial investigators/sites
Managing clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc.) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals.
Providing support to Field Clinical Research Associates (CRAs) and assisting in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites.
Coordinating and managing vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clinical Research Organizations (CRO).
Being the primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO's performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work.
Overseeing research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
Facilitating information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate.
Ensuring completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF)
Assisting in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections.
Experience running global studies from beginning to end.
Extensive study management/leadership experience start-up, maintenance & close out.
Experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend.
Understands how to work with vendors to accomplish tasks.
Dotted line reporting - leading CRA team functions.
Minimum of 3 years of trial management experience preferably at CRO or Pharma
This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #LI-REMOTE