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Global Study Lead - 12 month contract - Remote

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 8th July
Location: Cambridge
Salary/Rate: Upto £500
Type: Contract

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The Global Study Leader, Early Oncology Clinical is responsible for the delivery of clinical studies including quality, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines.Provides matrix management of functional area representatives to cross functional clinical study teams. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required.Typical Accountabilities:* Leads the delivery of the clinical study from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards* May convene and lead the cross functional study team(s) for Early Oncology Clinical studies based on delivery model* Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate manager or CRO representative* Contribute to preparation and delivery of study documents (e.g. Protocols/amendments, Informed Consent Form (ICF) documents detailing study delivery data management activities, etc.)* Responsible for forecasting and day-to-day management of study timelines, budget, materials and detailed study level plans and feasibility assessment* Implement agreed study level process and technology for Early Oncology clinical studies* Manage to the agreed study timelines, budget, and resource and ensure the update of appropriate systems* Accountable for the quality of study planning information into relevant planning systems* Guide the study team in the development of outsourcing specifications and vendor selection* May manage the vendor(s) throughout the life of assigned clinical trial(s) based on delivery model* Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs* Lead and conduct investigator meetings and other study related meetings* Identify and communicate resource gaps for assigned studies* Communicate study level reports and status updates for Early Oncology clinical studies* Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance* Oversee the submission of trial-related and essential documents to the Trial Master File, maintenance and final closeout of TMF* Ensure sponsor oversight throughout the life of the study* Lead risk management and quality efforts to ensure study compliance and continual inspection readiness* Responsible for study level reporting of progress, risks and issues* Provision to procurement clear specifications for study specific outsourcing* Review and operational approval of study specific contracts or work ordersPlease click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales