Fantastic Contract opportunity with a global Pharmaceutical organisation for a Clinical Trials Submissions Manager. This post can be based in Kent or Surrey.
Provides an interface to Regulatory and partners, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions.
The Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
* Drive global submission management activities.
* Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
* Support and leads global team efforts to ensure high quality components and submissions.
* Liaises with Study Management, regarding essential core documents.
* Prepare, review and submit submissions, in order to obtain all necessary authorisations /approvals pertaining to the clinical trial conduct.
* Responsible for the co-ordination of translations for core documents required for submission
* Manages the compilation for core package build, contributing to CTA and authoring documentation as required
* Acts as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory (CTR).
* Coordinates submission production and assists with definition, development, and implementation of global submissions policies and technologies to meet evolving business needs.
* In-depth understanding and proven execution of CTA processes globally
* Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.
* In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
* Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
* Understanding of EU Clinical Trial Regulation Desirable
* Familiarity with pharmaceutical organisational structures, systems, and culture is preferred
Job Title: Global Clinical Trial Submission Manager
Reference No: 237510
Location: Kent or Surrey
Job Type: Contract - 12 months
Rate: £400-£440 per day (Ltd Company Basis)
- clinical trials
- clinical research
- clinical submissions
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