Job Title

Senior Clinical Study Manager

Salary

£46,000 - £59,999

Job Type

Clinical Study Monitoring/Leadership, Clinical Study Management/Operations, Clinical Project/Program Management, Project Control & Budgets

Location

Central/City

Employment Type

Permanent Job

Employer Type

Medical Research Charity

Seniority

Senior Executive/Team Leader

Duration

 

FTE Hours

Full Time 35 - 40hrs Per Wk

Vacancy Status

Open For Applications

Date Posted

Fri 22nd Aug 2008, 05:26pm

This new role, in a widely respected, research driven charitable organisation, gives scope for experienced clinical research manager to adapt their skills to the not for profit sector.
The role reports directly to the Clinical Research Manager who is responsible for the direction of all clinical research activities in the orgnaisation.

Summary of duties
To manage phase I/II clinical trials in oncology within a matrix structure in order to ensure compliance with CR-UK policies, EU Directiveand regulatory ICH GCP guidelines and ensure the trials are conducted within agreed timelines
To develop and maintain good working relations with investigators, site staff, third party vendors and pharmaceutical companies where appropriate
Works closely with the project manager to ensure allocated studies meet key milestones within an agreed budget.
Chairs and facilitates clinical study team meetings and/or prepares/signs off meeting minutes and study status reports.
Identifies and helps assess potential study centres. In conjunction with study team, decides on suitable centres.
Oversees and advises junior CSMs in setting up new projects.
Source of advice to other CSMs, CRAs and the rest of the Drug Development team


Qualifications required
Biological Sciences degree or equivalent nursing qualification/experience
Experience in monitoring or co-ordinating clinical studies - with evidence of successful adherence to study timelines and an understanding of key issues surrounding trial management.
Experience in oncology is essential
Experience in developing protocols and setting up early phase clinical oncology trials
Experience of writing final clinical study reports
Experience of working to ICH GCP guidelines