i-Pharm Consulting

Manager Clinical Quality Oversight (GCP) – New Jersey – Pharma

New Jersey
09 Jan 2019
23 Jan 2019
Quality, QA / QC
Contract Type
Manager Clinical Quality Oversight (GCP) – New Jersey – Pharma

Manager Clinical Quality Oversight required to work for a busy and exciting medium to large sized Pharmaceuticals organization. Their focus has been on Generics and APIs. As a result of there success, they are on a mission to also innovate molecules in the areas of oncology, respiratory and dermatology.

This position will be based on their New Jersey site located deep in the heart of Mahwah. If you didn’t already know, Mahwah is one of the main life science ‘hubs’ of NJ. The site is also under 4 miles from a small Ski area – perfect if like me, the snow calls to you!


Manager Clinical Quality Oversight GCP


USA / New Jersey / Mahwah


Highly competitive salary (DOE)


* You will be the “go to” person for supporting all clinical operations teams by identifying protocol critical data and processes, protocol risk assessment, and site risk indicators that lead to quality concerns.
* In a nutshell - you will collaborate with Quality Management to ensure gaps or other observations related critical protocol data or processes, risk assessments, etc. are addressed and resolved
* As the Manager Clinical Quality Oversight you will lead and contribute to process improvement and knowledge-sharing within R&D teams.
* Your main areas of responsibility will be; periodic reviews of clinical trial data, audit reports, and site data. Early identification of risks occurring during study conduct. Also, to assess quality of data for new sites and sites with high query rates - show how protocol changes are implemented at the site.
* Other things required in the role; contribution to sponsor oversight, conduct accompanied site visits, presenting issues and recommendations to stakeholders, SOP and Associate Document creation. Performing trending analysis of key findings.


* A proven track record and 10 years (minimum) of clinical research experience as a Lead CRA or CRA Manager, or similar clinical monitoring leadership role.
* Bachelor’s degree in a science discipline
* In depth Knowledge of GCP requirements, regulations and Quality
* Be open to travel 20% of the time
* Recent working experience of collaborating with cross functional and global teams
* Meticulous with written skills and experience of prioritising / planning
* Unparalleled communication skills and the ability to influence others
* Be real life “self-starter”


i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.



If you would like to discuss this vacancy further, please call Senior Recruitment Consultant David Fearnley on +1 (718) 514-9604, or email dfearnley@i-pharmconsulting.com. If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


Vendor Quality Oversight Manager GCP / Vendor Quality Oversight Manager Clinical / Vendor Quality Oversight / USA / New Jersey / Infectious / Mahwah / NJ / GMP / Regulatory / Validation / Qualification / SOP / Quality / QA / GCP / Vendor / CRO / Florham / Clinical / CRA / Monitoring / QA / Risk / Report / Training / Oversight / Sponsor / Site / Travel

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