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Senior Clinical Trial Manager - FSP (remote anywhere in US or Canada)

Parexel International Corporation

Multiple Locations

Position Purpose:

The Senior Clinical Trial Manager position has two primary responsibilities: Execution of the clinical trial including site management functions, and management of staff (indirect) within the clinical study team.

Primary Duties: Act as Protocol Lead on large complex clinical trials, including Global Phase 3 trials, or several smaller clinical trials. Serve as the main point of contact for clinical site management and clinical trial site monitoring functionsParticipate as a member on assigned cross functional study teamWill assist 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. Participate in the Clinical Protocol Committee as appropriate.Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan. Develop or provide 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.Participate in the identification, evaluation and selection of clinical trial investigators/sitesManage 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.Provide support to field CRAs and may assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. May conduct monitoring visits including pre-study, initiation, interim monitoring and close visits as needed.Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clincial Research Organizations (CRO).Primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to theterms of contract, CFR, ICH/GCP compliance, and overall quality of work.Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.Facilitate 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.Ensure completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies.Participate in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections.Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related trainingAdheres to EP and Client SOPs and processes

Management:Manage assigned study team (indirect), providing timely feedback on project performance.Ensure assigned clinical study team adheres to clinical operations or project-specific quality documents (e.g., SOPs, work practices, training guides).Review and revise clinical study team project assignments as needed to balance workload.

Skills and Education: BA/BS or equivalent or any relevant and qualifying training. Experience in the pharmaceutical industry is required. An advanced degree is a plus.Experience managing personnel is required.Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required.Excellent leadership, communication and organization skills.Exceptional ability to plan, organize and conduct clinical studies with minimum oversight.Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)

Job posted: 2022-08-12

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