EU CLINICAL TRIAL SUBMISSION jobs in United Kingdom

for submission to ECs and HAs. Prepare the data required in CTIS for global Clinical Trial Application dossiers... lives. Read more: The Submission Manager, Clinical Trials manages and coordinates the timely, compliant, and accurate...

for submission to ECs and HAs. Prepare the data required in CTIS for global Clinical Trial Application dossiers... lives. Read more: Position Purpose The Submission Manager, Clinical Trials manages and coordinates the timely, compliant...

The Role: Responsible for all aspects of clinical trial management. The post holder will have a significant level... or equivalent in biomedical, health of life science field Proven clinical trial experience, clinical trial management; CRO...

for all aspects of clinical trial management. The post holder will have a significant level of responsibility. Duties will include... standardization of trial conduct in accordance with all regulatory standards. Key Objectives/KPI’s Design clinical...

clinical trial submissions. Medpace specialises in supporting mid-sized biopharma companies giving you the opportunity to work... documents for compliance with relevant guidelines/regulations and for trial suitability; Prepare and maintain Part I EU CTR...

! Responsibilities Manage the study start up process through site activation, working with Project Manager and Clinical Trial Lead... take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve...

control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Clinical Editor...'s Brochures, and Module 2 clinical summary documents) to ensure compliance with the Incyte Style Guide and submission standards...

and accuracy of all core documents for local EC submission, as applicable, for in-house clinical studies (i.e. submission pack... Trial Managers (CTMs), Global Regulatory and other as work needs Qualifications At least 5 years clinical research...

Description FSP Senior Clinical Research Associate II Syneos Health® is a leading fully integrated biopharmaceutical solutions... organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights...

-submission meetings Experience handling PIP applications and orphan designation Experience managing Clinical trial applications... to run clinical trial applications by ourselves, ADVANZ may be the sponsor for any new or ongoing clinical trial, in...

), paediatric plans, clinical trial designs and HA feedback. Accountable, with the GRSL, for providing a regulatory recommendation... with external companies and the internal diligence team on discrete products for multiple indications, from pre-clinical development...

for use across Achilles clinical trial programmes. This role will play a key part in establishing, growing, and maintaining the quality... requirements relating to clinical trial manufacture are met and maintained for ATIMPs (Advanced Therapy investigational Medicinal...

(Investigational Medicinal Product), thereby ensuring GxP and other regulatory requirements relating to clinical trial manufacture... and its Review Desirable: Understanding of Clinical Trial Directives/Regulations Knowledge about Regulatory Requirements...