(Freelance) Clinical Study Manager - Oncology / Rare Diseases

Job title : (Freelance) Clinical Study Manager - Oncology / Rare Diseases
Location : England
Job type : Contract/Freelance
Salary : £65.00 - £75.00 per hour
Contact name : Roy Nelson
Contact number : +44 (0) 207 255 6620
Contact email : roy.nelson@seclifesciences.com
SEC Life Sciences are advertising an exciting opportunity for a (Freelance) Clinical Study Manager to work on Oncology breakthrough biologics proprietary molecules of an internationally-renowned pharmaceutical company.

This is a 12-months, full-time, homebased role in the UK.

The Clinical Study Manager (CSM) will be responsible for ensuring study deliverables are met within time and budget. To do so, a strong collaboration and management of vendors will be required. In addition, the CSM will be co-ordinating and supervising clinical monitoring team through effective monitoring plan and scheduling, whilst being a primary point of contact with country/region specific participating sites.


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 5 years of experience in clinical operations and MIN 2 years as a Clinical Trial / Study Manager
* Experience working on Oncology or Rare Diseases global, regional or local trials.
* 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 ask to speak to Roy to enquiry additional information.

Ref Numb: 128066 to enquiry additional information.