Quality Trial Oversight Manager

Location: High Wycombe Salary: £48.00 - £53.01 per hour
Sector: Life Sciences, Pharmaceuticals, Medical Communications, Medical Devices Specialism:
Type: Contract Contact: April Burton

Quality Trial Oversight Manager

High Wycombe

Minimum 6 month contract


Quality Trial Oversight Manager needed for a multinational pharmaceutical organisation based in High Wycombe who are looking for an experienced Quality Trial Oversight Manager with an in-depth knowledge of the drug development process and experience in research and development.

My client is looking for someone to join them for a minimum 6 month contract. Although this is a 6 month contract, my client encourages progression and growth within the company and contracts do get extended.
The successful Quality Trial Oversight Manager will be based in High Wycombe a minimum of 3 days a week and remote working can take place for the other 2.

What the role entails:
* Develops and executes the Integrated Quality Plan (IQP), with guidance from the QP&S IQP leader and/or the Program Leader.
* Develops, maintains and execute trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
* Actively participates in pre-study activities, contributing to the identification of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
* Ensures that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.
* Monitors risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.
* Facilitate Quality Working Group (QWG) meetings.
* Assists/Lead in the development of materials for Stage Gate Review, as needed.
* Develops and executes strategy to ensure inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections, as needed.
* Consults with appropriate business partners and peers within BRQC to develop and implement Corrective and Preventative Action Plans (Self Identified, Inspection.)

What you need to be the successful Quality Trial Oversight Manager:
A minimum of 4 years within an R&D environment is essential along with drug development.
* A minimum of a Bachelor's Degree is required, preferably in a science or technical related discipline.
* A minimum of 8 years of relevant professional experience is required.
* A minimum of 4 years experience working in a R&D environment in the pharmaceutical/, Medical device and/or consumer industries are required.
* Knowledge of the drug development process and good knowledge of worldwide GCP (Good Clinical Practice) is required.
* Experience in a R&D/Quality/Auditor role with a clinical trial focus is required.
* Ability to interpret data to develop action plans to improve business is required.
* Experience with regulatory submissions (NDA, BLA) is preferred.
* Knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development is required.

This is a really fantastic opportunity for a Quality Trial Oversight Manager to progress their career. If you are interested, please apply as soon as possible. This position will be filled quickly so don't miss out!

Quality Trial Oversight Manager
High Wycombe
Minimum 6 month contract

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