EU CLINICAL TRIAL SUBMISSION jobs in UNITED KINGDOM, United Kingdom

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...

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...

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...

serving as a Clinical Trial Submission Coordinator/Lead, overseeing complex large clinical trial submissions... level of knowledge of Clinical Trial Submissions on a local and regional level Working knowledge of submissions under EU...

, ensuring effective collaboration between departments. Your role may also involve serving as a Clinical Trial Submission... level of knowledge of Clinical Trial Submissions on a local and regional level Working knowledge of submissions under EU...

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...

) Type of Contract Permanent Job Status Full-time Is the job funded through the EU Research Framework Programme? Not funded... by an EU programme Is the Job related to staff position within a Research Infrastructure? No...

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...

within the Site Start-Up. Acts as country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures... requirements of the clinical trial. Local Investigator Contract and Budget Negotiator - Produces site-specific contracts...

submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial...Overview Regulatory Affairs Manager- (EU CTR) Homebased in UK/Ireland Only Due to recent success...

-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...