TMF Lead II
2 weeks ago
As 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 conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are looking for an experienced TMF specialist for our TMF Lead II position. This is an office-based role in Maidenhead. Will initially mainly support paper TMF tasks, as required: Key Responsibilities:- 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.
-
TMF Lead II
Found in: Talent UK C2 - 1 week 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...
-
TMF Lead II
Found in: beBee S GB - 3 weeks 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...
-
TMF Lead II
Found in: Talent UK C2 - 2 weeks 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...
-
Data Lead for Performance
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. This is an office-based...
-
CRA II
Found in: Talent UK C2 - 1 week 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...
-
CRA II
Found in: beBee S GB - 3 weeks 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...
-
CRA II
Found in: Talent UK C2 - 2 weeks 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...
-
Accountant II
2 weeks ago
Maidenhead, Berkshire, 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...
-
Accountant II
Found in: beBee jobs GB - 2 weeks 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;...
-
Accountant II
Found in: beBee S GB - 3 weeks ago
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;...
-
Senior Medical Writer
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. Imbedded in the team of...
-
Statistical Programmer
1 week ago
Maidenhead, Berkshire, United Kingdom BeOptimized SRL Full timeFortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering ... Expert knowledge of base SAS , SAS macros, SAS /STAT and in debugging SAS programs; Knowledge of R will be a big plus; Broad knowledge of all CDISC requirements ... Statistical...
-
Sr Clin Res Assoc Ii
2 days 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;...
-
Sr Clin Res Assoc Ii
2 weeks ago
Maidenhead, United Kingdom Labcorp 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;...
-
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...
-
SCRA - London
Found in: Talent UK C2 - 1 week 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...
-
Senior Clinical Research Associate
2 weeks ago
Reading, Berkshire, United Kingdom IQVIA Full timejoin us on our mission to drive healthcare forward! We are recruiting for a Senior Clinical Research Associate to assist our sponsor’s Early Development team (phase 1). This is a fully remote position (open to candidates anywhere in the UK) with travel to sites. Professional development - resources that promote your career growth and programs to help...
-
Clinical Research Associate
2 weeks ago
Reading, Berkshire, United Kingdom IQVIA Argentina Full timeOur Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward! The chance to work on cutting edge medicines at the forefront of new medicines development IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and...
-
Clinical Research Associate
2 days ago
Reading, Berkshire, United Kingdom IQVIA Argentina Full timeClinical Research Associate (all levels) Sponsor Dedicated, Home Based, UK Remote/Hybrid/Office based working options. Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward! As Clinical Research Associate you will be responsible perform monitoring and site management work to ensure that sites are conducting...
-
Senior Regulatory Medical Writer, sponsor-dedicated
Found in: Talent UK C2 - 1 week 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...