United Kingdom · Remote Solely
TMF Representative Join a team that's going places! Every member of Celerion is involved in making a distinctive contribution to the health and well-being of people around the world. That's the sense of purpose shared by…
Skills: Document management, Clinical research, Trial master files, Interpersonal skills, Oral communication
Fehraltorf, Zurich, Switzerland · On-site
Celerion is one of the world's leading bioanalytical contract research organizations and has been supporting pharmaceutical and biotech drug development programs around the world for more than 40 years. Due to the steady…
Skills: Liquid handling, Automation, Hamilton robots, VENUS software, EVOware
Fehraltorf, Zurich, Switzerland · On-site
Celerion ist eines der weltweit führenden Unternehmen der bioanalytischen Auftragsforschung und unterstützt seit mehr als 40 Jahren Pharma- und Biotechfirmen auf der ganzen Welt. Celerion bietet Dienstleistungen für die …
Skills: Quality control, Data review, Bioanalytical studies, LBA, LC-MS/MS
United States · Remote OK
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you look…
Skills: Veeva CDMS, Veeva EDC, Veeva CDB, SQL, Clinical Data Management
Northern Ireland, United Kingdom · Hybrid
Join a team that's going places! Every member of Celerion is involved in making a distinctive contribution to the health and well-being of people around the world. That's the sense of purpose shared by our employees. We …
Skills: SAS, Clinical database programming, Data management, Clinical trial set-up, Data import
Lincoln, Nebraska, United States · On-site
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. As a Researc…
Skills: Clinical research, Database management, Documentation, Communication skills, Organizational skills
Richmond, Virginia, United States · Hybrid
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is …
Skills: Customer service, Communication skills, Data entry, Sales, Telemarketing
Lincoln, Nebraska, United States · On-site
$15/hr–$15/hr
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. As a Custodi…
Skills: General Cleaning, Sanitizing, Trash Removal, Laundry, Customer Service
Richmond, Virginia, United States · On-site
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is …
Skills: Sample Management, Inventory Control, Electronic Inventory Systems, Microsoft Word, Microsoft Excel
Lincoln, Nebraska, United States · On-site
$20/hr–$22/hr
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. In this posi…
Skills: Pharmacy Functions, Clinical Sample Management, FDA Laws, Controlled Substance Laws, Microsoft Word
Tempe, Arizona, United States · On-site
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. As a Medical…
Skills: Spanish-English Bilingualism, Electronic Medical Records, Medical Admissions, Participant Screening, Database Management
Lincoln, Nebraska, United States · Hybrid
$22/hr–$23/hr
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is …
Skills: SOP Design, Project Management, Document Control, Regulatory Compliance, Training Facilitation
Tempe, Arizona, United States · On-site
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Job Purpose …
Skills: Customer Service, English Proficiency, Spanish Proficiency, Interpersonal Skills, Problem-Solving
Fehraltorf, Zurich, Switzerland · On-site
Help bring tomorrow's medicines to patients. At Celerion Switzerland AG, part of the global Celerion Inc., we support pharmaceutical and biotechnology companies in developing innovative medicines. Our GLP-certified bioan…
Skills: Bioanalytical Measurements, Immunoassay (LBS), LC-MS/MS, Sample Preparation, GLP Compliance
Lincoln, Nebraska, United States · On-site
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Bring your c…
Skills: Sterile Technique, Pipetting, Biological Sample Processing, Reagent Preparation, Analytical Testing
Lincoln, Nebraska, United States · Hybrid
$20/hr–$21/hr
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are curre…
Skills: Clinical Trial Logistics, Electronic Data Capture, ClinQuick, Study Conduct Manuals, Event Scheduling
Fehraltorf, Zurich, Switzerland · On-site
Shape the future of bioanalysis for innovative medicines Celerion is a leading global contract research organization (CRO) specializing in early clinical research and bioanalytical services. For more than 40 years, we ha…
Skills: Ligand Binding Assays, Cell-Based Assays, GLP Compliance, GxP Compliance, Study Direction
United States · Remote OK
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are seeki…
Skills: Budget Development, Pricing Strategy, Financial Forecasting, Proposal Support, Microsoft Excel
Tempe, Arizona, United States · Hybrid
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a …
Skills: Clinical Monitoring, People Management, Site Management, GCP Compliance, Clinical Trial Management
Lincoln, Nebraska, United States · On-site
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is …
Skills: Clinical Assessment, Vital Sign Checks, ECG, Blood Draws, Telemetry Monitoring
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The TMF Representative is responsible for the preparation, maintenance, and indexing of Trial Master Files to ensure compliance with study protocols and regulatory requirements. They will also act as a point of contact for sponsors, project managers, and study sites to facilitate effective communication and study documentation.
Candidates must hold a bachelor's degree in a science or biomedical discipline and possess at least one year of document management experience. Proficiency in Microsoft Office applications and strong organizational and communication skills are required for this role.
Join a team that's going places! Every member of Celerion is involved in making a distinctive contribution to the health and well-being of people around the world. That's the sense of purpose shared by our employees. We are a performance-driven drug research company, operating in robust and growing markets. We have an exciting future and offer a competitive salary in a strong developmental environment.
Celerion, a leader in the clinical research industry, currently has an opportunity for a TMF Representative to join our team. This is a remote, home-based position within the UK. Applicants must have full and permanent right to work in the UK, Celerion does not currently offer Sponsorships.
In this position, you will be responsible for the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for the TMF services to meet Sponsor negotiated specifications. You will be responsible for maintenance of the Trial Master File, creating a file structure and indexing contents. You will also communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements.
\nRequirements
Are you ready to join our team?
Celerion is an Equal Opportunity Employer.
Celerion Can Take You from First-In-Human through Proof-of-Concept.
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
Offices: 621 Rose Street, Lincoln, NE 68502, US · 2420 W. Baseline Rd., Tempe, AZ 85283, US · 100 Boulevard Alexis-Nihon, Montreal, Quebec H4M, CA · 22-24 Lisburn Road, Belfast, BT9 6AD, GB · Allmendstrasse 32, Fehraltorf, CH
Celerion Can Take You from First-In-Human through Proof-of-Concept.
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
Offices: 621 Rose Street, Lincoln, NE 68502, US · 2420 W. Baseline Rd., Tempe, AZ 85283, US · 100 Boulevard Alexis-Nihon, Montreal, Quebec H4M, CA · 22-24 Lisburn Road, Belfast, BT9 6AD, GB · Allmendstrasse 32, Fehraltorf, CH
