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Traffic Management Operative
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SoundHR LTD Remote, United KingdomOpportunities at Circet · **Position**: Traffic Management Operative - FREEFLOW -East Kilbride · Full Time Permanent · **Main Purpose**: · Reporting to the Operation Manager, the TM operative will be responsible for the install, maintenance and removal of all site-based traffic m ...
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Operations Manager
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Charity Challenge Remote, United Kingdom OTHERPosition: Operations Manager · Job Type: Temporary. Minimum of 9 months Maternity Cover – starting in Aug 2024, with potential to extend if the maternity leave is extended · Department: Operations Team · Reporting to: Head of Operations · Direct reports: None · Location:Main offi ...
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Leader, Operations + Channels
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Operations Assistant
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Clinical Study Team Lead
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Head of Technical Operations, Education Services
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Delivery Operations Lead
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Part Time Head of Operations
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Operational Change Specialist
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Operational Excellence
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Leader, HR Operational Risk, Tax
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Environmental Health
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Itsm Consultant
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Operations and Programmes Coordinator
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Commercial Service Delivery Executive
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Account Support Executive
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Operations and Administration Officer
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Financial Crime Operations Team Leader
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Head of Customer Experience
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Clinical Operations Manager - REMOTE, United Kingdom - Parexel
Description
Parexel FSP is currently looking for a Clinical Operations Manager (Regulatory) to join our expanding team in the UK.
This will be a home-based position.
Working at Parexel offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. We have an incredible pipeline of work and a world of opportunity waiting for you.
The Clinical Operations Manager (Regulatory) is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Experience required to be a fit for this role:
· Mandatory – Extensive experience in local EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission.
· Experience in Independently preparing submissions (CTC supports with documents collection) to both EC and RA.
· Experience in ICF preparation using templates.
· Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
· Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
· Experience in validation of translated documents.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Who are Parexel?
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today's top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You'll be an influential member of the wider team.
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