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Study Lead
1 day ago
Technip Energies London, United KingdomStudy Lead · At Genesis, we are our clients trusted advisors on the journey to a sustainable future. For over 30 years, Genesis has developed an unrivalled track record and reputation for high quality, high impact solutions. We work in true partnership with our clients and are pr ...
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Study Lead
1 week ago
Clearline Recruitmentment Ltd Welwyn, United KingdomOur client is a globally leading pharmaceutical company, who are looking for a Study to join their team based in Welwyn, on a 12-month contract basis. This is a hybrid role, with 2-3 days per week in the office. · **Responsibilities** · - Drive Study Strategy by designing study s ...
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Study Design Lead
2 days ago
Labcorp Maidenhead, United KingdomGet ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp Drug Development, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support ...
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Study Design Lead
2 weeks ago
Labcorp United KingdomGet ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional pe ...
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Marketing Case Study Lead
1 week ago
Sopra Steria Hemel Hempstead, United Kingdom Part time**Are you looking for an exciting role that will add value to a business?** · We are looking for a dynamic and organised individual to join the Storytelling and Design team which sits within the fast-growing marketing function, to provide maternity cover for 12 months. This role ...
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Study Manager Team Lead
1 week ago
Hyper Recruitment Solutions LTD England, United KingdomWe have an exciting new opportunity for a Study Manager Team Lead to join a leading international CRO based in the North Yorkshire area. As the Study Manager Team Lead you will be responsible for directly line managing a team of Study Managers for regulatory and non-regulatory sm ...
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Study Manager Team Lead
5 hours ago
Hyper Recruitment Solutions England, United KingdomWe have an exciting new opportunity for a Study Manager Team Lead to join a leading international CRO based in the North Yorkshire area. As the Study Manager Team Lead you will be responsible for directly line managing a team of Study Managers for regulatory and non-regulatory sm ...
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Subject Lead for Business Studies
2 weeks ago
Robert Barclay Academy United KingdomSalary – TLR 2a (plus £1500 for Enterprise across the school for the right candidate) · Other Scholars' Education Trust benefits are also available . · Robert Barclay Academy is part of Scholars' Education Trust. We are seeking to appoint a hardworking, ambitious and dynamic t ...
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Lead Teacher of Food Studies
1 week ago
LONDON BOROUGH OF BRENT SCHOOLS United KingdomName of Executive Headteacher - Russell Denial · Salary: Inner London Teachers Pay Scale plus additional allowance GBP2,000 · Hours: Full time, permanent (0.8 FTE part time position considered) · Making school memorable by striving for excellence · The Post: · You will: ...
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Subject Lead for Business Studies
5 days ago
Robert Barclay Academy United KingdomSalary – TLR 2a (plus £1500 for Enterprise across the school for the right candidate) · Other Scholars' Education Trust benefits are also available . · Robert Barclay Academy is part of Scholars' Education Trust. We are seeking to appoint a hardworking, ambitious and dynamic t ...
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Lead Teacher of Religious Studies
1 week ago
The Priory Learning Trust United KingdomLead Teacher of Religious Studies · Plus TLR 2.1 £3,214 (gross, per annum) · Fixed Term Maternity Cover until 31 August 2025, subject to the return of the post holder. · 1.0 FTE · TMS/UPS · Plus various Company Benefits · The Priory Learning Trust is looking to recruit a Lea ...
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Lead Teacher of Business Studies
5 days ago
Harris Lowe Academy Willesden London, United Kingdom Full timeWe are currently looking to appoint a dedicated and inspiring Lead Teacher of Business Studies. · At Harris Lowe Academy Willesden, you will join a dedicated team of teachers and staff supporting our excellent students. If you are looking for an opportunity to grow, inspire and d ...
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Global Study Start-Up Lead
2 weeks ago
Advanced Group London, United Kingdom Regular Full time***This is a work from home position that can be worked from anywhere in Europe*** · The Global Study Start-Up Lead is responsible to advance study start-up and regulatory activities by understanding the client objectives and assist in the development of the plan for country and ...
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IQVIA LLC United KingdomAssociate Director, Study Lead, Single Sponsor Dedicated page is loaded · Associate Director, Study Lead, Single Sponsor Dedicated · Apply locations Reading, Berkshire, United Kingdom time type Full time posted on Posted 30+ Days Ago job requisition id R Job Purpose · The Sen ...
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Lead Teacher of Food Studies
1 week ago
Preston Manor School Wembley, United Kingdom Full timeThe success of Preston Manor School is built on an 80-year old reputation which continues to flourish through its committed staff, dedicated Governors and supportive parents. · We are an all-through school with students ranging from 4 – 19 years. Staff are expected to make the m ...
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Study Delivery Lead
5 days ago
GlaxoSmithKline Stevenage, United Kingdom Full timeSite Name: UK - Hertfordshire - Stevenage · Posted Date: Mar · Study Delivery Lead - Value, Evidence and Outcomes (VEO), Vaccines · Are you a clinical operations professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a ...
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Lead Practitioner of Business Studies
2 weeks ago
Harris Girls' Academy Bromley Beckenham, United Kingdom Full timeWe are looking for a qualified, experienced teacher to join us as Lead Practitioner of Business Studies. · About UsAt Harris Girls Academy Bromley we have built a school community where we hold character and academic excellence in equally high regard. · Progress 8 for the school ...
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Business Studies Teacher
4 days ago
Clarus Education Ltd London, United Kingdom Full timeBusiness Studies Teacher – Leading Inner London School – ZONE 2 – September 2024 · We are looking to recruit a talented, passionate and engaging Business Studies Teacher for a full time, permanent post, starting September 2024. · If successful, you will join a leading London Seco ...
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Facilities Lead
2 days ago
Kin-Tec London, United KingdomFacilities Development Engineer - £80k - £110k base plus benefits - South East · Job Title: Facilities Development Engineer · Location: South East London, UK · **Salary**: £80K - £110K · As a Facilities / Development Lead you will work directly with our clients, to develop an und ...
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Trainee Business Studies Teache
1 week ago
Ribbons and Reeves Limited London, United Kingdom Full timeTrainee Business Studies Teacher - September 2024 · Are you a recent graduate with a passion for Business Studies and an interest in teaching...? · We are seeking a highly motivated and enthusiastic Trainee Business Studies Teacher to join our dynamic team through a London-leadin ...
Clinical Study Lead - United Kingdom - Oxford Global Resources
Description
Oxford Global Resources is hiring a Clinical Study Lead (IVD experience is a must) for temporary maternity leave.As a Clinical Study Lead/Trial Manager you will be responsible for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.
The Trial Lead is responsible for creating and implementing study-specific clinical monitoring tools and documents; responsible for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, trouble shooting, and prevention planning.
Also:
Accountable for ensuring study site preparation, equipment, and training are compliant to the clinical protocol and organization's SOPs.
Responsible for clinical study data entry and audit; adherence to all regulations including patient privacy per organizational policies.
Coordinating and supervising clinical monitoring team.
Providing Clinical Research Associates with project-specific training and having regular meetings with them.
Arranging and overseeing site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality.
Accountable for study close out procedures on study binders, datasets and study supplies working with CTAs, CRAs and Data / Statistic stakeholders for close-out documents and reviews.
Authors clinical study reports and study related submission documents to regulatory authorities, IRBs and local agencies in line with their requirements.
Accountable for supplementing data or documents for any queries from authorities during submission procedures. Support CA function input for studies during audits e.g. BIMO, Pharma partner, FDA.Education:
Bachelor's degree in, life sciences, biomedical engineering or nursing5-8 years working experience with in vitro diagnostic devices company.
Minimum 3 years working experience in Clinical Affairs/Operations is preferred, but experience in product development, quality and regulatory will be considered as part of overall professional experience.
Working experience in clinical study management including good clinical practice is preferred . YesWorking knowledge of Regulatory requirements e.g. FDA CFR, ICH GCP, ISO14155, IVDR. Proficient with Microsoft Office Word and Excel. Understanding of Electronic Data Capture (eDC), eTMF and CTMS or similar clinical operations systems. Proficient English oral and written communication.