Clinical Trial Manager-home-based

Execupharm Uk Limited ,
London, Greater London
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Overview

For our European operations we are currently looking for a Clinical Trial Manager who will perform their work responsibilities in their European home-office. The Clinical Trial Manager will be responsible for the site and staff management while working with the cross functional teams. Successful individual will be rewarded with a permanent, fully home-based position within ExecuPharm, competitive base salary combined with a benefits package as well as numerous career progression opportunities within our international Organization. Principal Responsibilities ·Act as Protocol Lead on one or more clinical trials and serve as the main point of contact for clinical site management and clinical trial site monitoring functions ·Participate as a member on assigned cross functional study team ·Assist with the review of clinical trial protocols, informed consent, CRFs, Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups ·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 ·Participate in the identification, evaluation and selection of clinical trial investigators/sites ·Manage 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 project CRAs and assist in the initiating, monitoring and coordinating day-to-day operations of clinical trial sites. May conduct monitoring visits and site visits as needed ·Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories, FSP vendors and CROs ·Primary contact for Clinical Trial Site Monitoring Team to ensure performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work ·Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team ·Ensure completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies ·May assist in the preparation and follow-up of in-house and on-site quality audits, as well as, regulatory authority inspections ·Establish and maintain good personal relationships with investigators and key opinion leaders in various therapeutic areas ·Support the European Headquarters team across various functions, representing the clinical operation function ·Attend regional and international conferences and congresses to represent company ·Problem-solve clinical team personnel issues as well as performance issues of CROs/vendors ·Ensure staff training is adequate and documentation of training is up to date ·Should assume responsibility for development and maintenance of some department SOPs or processes ·Participate in the screening, evaluation and hiring process for assigned open clinical operations positions ·Support European Headquarters across various departments and functions Qualifications ·5-8 years of relevant Pharmaceutical/Biotech/CRO Industry experience preferred ·Experience in Phase I-III trials required, experience in CRO management is a plus ·Oncology clinical research experience required ·Ability and willingness to travel is required (domestic and international) ·Thorough knowledge of CFR and GCP/ICH requirements. Knowledge of European Clinical Trial Directive required, knowledge of regulations on a country level in different EU countries ·Excellent communication and organization skills ·Experience in working within complex matrix organizations and across different teams ·Exceptional ability to plan, organize and manage clinical trials ·Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF) Education ·BA/BS in Life Sciences OR equivalent preferred ·Advanced degree in life sciences is a plus This job was originally posted as www.totaljobs.com/job/89797954

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