TMF Lead II
2 weeks ago
- Maintenance of a paper Trial Master File (TMF) in accordance with applicable SOPs and ICH-GCP guidelines, and study-specific TMF Index.
- Maintaining a paper TMFs in a state of audit readiness for quality and Fortcompliance.
- Reviews TMF documents according to the ALCOA+ principles.
- Processes (print, code and file) final documents required throughout all phases of the study.
- Raises queries to the project team in case a document issue is detected and follow up until query resolution.
- Resolving QC issues raised by the project team during project team QC, if applicable.
- Working with key study personnel such as the Project Manager or Clinical Study Lead to resolve any filing issues.
- Prepares the paper TMF for QA or client audits & inspections, as well as project team or Sponsor physical paper TMF QCs.
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Tmf Lead Ii
2 weeks ago
Maidenhead, United Kingdom Pharmiweb Full time**TMF Lead II (office-based)**: - Job Reference: 1329128179-2 - Date Posted: 18 May 2024 - Recruiter: Pharmiweb - Location: Maidenhead, Berkshire - Salary: On Application - Sector: Business development, Creative & design, Print, Technology - Job Type: Permanent As a leading global contract research organization (CRO) with a passion for scientific rigor and...
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TMF Lead II
2 months ago
Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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TMF Lead II
2 months ago
Maidenhead, Berkshire, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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TMF Lead II
2 months ago
Maidenhead, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Data Lead for Performance
2 months ago
Maidenhead, Berkshire, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. This is an office-based...
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CRA II
1 month ago
Maidenhead, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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CRA II
1 week ago
Maidenhead, United Kingdom Pharmiweb Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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CRA II
1 month ago
Maidenhead, United Kingdom Pharmiweb Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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CRA II
2 months ago
Maidenhead, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Biostatistician II
5 days ago
Reading, Berkshire, United Kingdom ICON Full timeICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We currently have an opportunity for a Biostatistician II to join the Biostatistics (Medical...
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Maidenhead, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Senior Clinical Trial Assistant
2 weeks ago
Reading, Berkshire, United Kingdom IQVIA Argentina Full timejoin us on our mission to drive healthcare forward! We are recruiting for a Senior Clinical Research Associate / Senior Clinical Research Associate II to assist our sponsor’s hematology studies. Professional development - resources that promote your career growth and programs to help you build knowledge and gain skills Work-life balance - leaders...
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Biostatistician II
5 days ago
Reading, Berkshire, United Kingdom ICON Full timeParis, Dublin, Warsaw, Lisbon, Bucharest, Johannesburg, Madrid, Reading ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We currently have an...
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Biostatistician II
5 days ago
Reading, Berkshire, United Kingdom ICON Full timeParis, Dublin, Warsaw, Lisbon, Bucharest, Johannesburg, Madrid, Reading ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We currently have an...
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Clinical Research Associate
1 month ago
Maidenhead, United Kingdom ABBVIE Full time**Clinical Research Associate II (CRA II)** - Field based role, with 25% travel requirement - Comprehensive benefits package including car allowance and excellent career opportunities The UK Clinical Operations team is the largest Clinical Development hub in Europe for AbbVie, joining as a CRA II, you will have the opportunity to take advantage of...
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Accountant II
2 months ago
Maidenhead, Windsor and Maidenhead, United Kingdom FM Global Full timeFM Global is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions. FM Global helps clients maintain continuity in their business operations by drawing upon state-of-the-art loss-prevention engineering and research;...
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Senior CRA
2 weeks ago
Reading, Berkshire, United Kingdom IQVIA Argentina Full timeOur cFSP (sponsor dedicated) team are growing; join us on our mission to drive healthcare forward! We are recruiting for a Senior Clinical Research Associate / Senior Clinical Research Associate II to assist our sponsor’s hematology studies. Why IQVIA? Growth potential - clear pathways to success for those who want to grow with us Professional...
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Senior Medical Writer
1 month ago
Maidenhead, Berkshire, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. Imbedded in the team of...
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Senior CRA I
2 weeks ago
Maidenhead, Berkshire, United Kingdom Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Sr Clin Res Assoc Ii
1 month ago
Maidenhead, United Kingdom Fortrea Full time1) The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. 2) Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits;...