|Job title :||Clinical Study Manager - Oncology/Rare Diseases|
|Location :||London, Greater London, England|
|Job type :||Permanent|
|Salary :||£55000 - £65000 per annum|
|Contact name :||Roy Nelson|
|Contact email :||email@example.com|
To break it down even further, this clinical-stage, start-up biotechnology firm holds a highly-innovative assay of immuno-oncology drug candidates which paves a solid fundamental for growth within a winning team that have recently been given FDA approval, secured top-tier pharma partnerships and new rounds of funds.
Main Responsibilities (not limited to):
* To plan, implement and execute on single or multiple clinical trials in compliance with ICH-GCP and regulatory requirements.
* To oversee CRO activities in relation to site management at regional and global level.
* To manage supplies and Third-Party Vendors assigned to the study(ies) to ensure timelines are defined and implemented.
* To monitor and review monitoring report metrics, potential data quality issues and level of protocol deviation trends.
* To perform oversight visits at selected sites in aid of evaluating site and CRA performance and overall adherence to operations plan, study protocol, ICH GCP and more.
* To review monitoring reports to ensure quality standards are met and escalate identified report issues to CRO study team and find issue resolution.
* To participate on start-up activities including site identification, feasibility, and selection.
* To act as subject matter expert for assigned protocol(s) to support with study-related issues or questions from CRO, regulatory bodies and third-party vendors.
Education and background:
* A minimum of 4 years of experience in clinical operations (currently a Lead CRA with 1+ years of leading experience).
* Experience working within a biotechnology or pharmaceutical company (ideal), and/or CRO.
* Experience from start-up through to close-out.
* Comprehensive knowledge of GCP-ICH guidelines and regulatory requirements (MHRA/EMA/CHMP)
* Ability to work autonomously with minimal supervision, as well ability to communicate and work effectively within a team.
To apply, click the button below or call +442072556620 and quote Ref Numb: 127215 to enquiry additional information.