Clinical Study Manager
(Full Time)

Cambridge, United Kingdom

Salary
£50,000 pa

Primary Role:

Design, develop, and execute protocols for clinical trials that fit with existing regulations and standards.

Write clinical trial notifications and investigational device exemptions for submission to regulatory bodies

Write and maintain clinical evaluation reports to the requirements of the Medical Device Regulation

Manage budget and schedule during clinical trials.

Write study documents, reports, and summaries of adverse events.

Submit reportable adverse events from clinical trials to applicable external bodies within legislated timelines

Develop and implement enrolment strategies, monitoring to adjust for dropouts.

Monitor and track progress and obstacles during clinical trial, responding to day-to-day problems

Manage post-market surveillance activities for registered products

Other Roles:

Work with external institutions and clinical staff that perform part of the clinical study work

Make changes to the trial structure and processes based on subject or team feedback

Analyse data based on trial results, interpreting research information, and creating detailed documentation using strict clinical procedures

Prepare manuals and present conclusions at conferences and seminars.

Assist with budget preparation

Oversee assessments that include screening and testing procedures

Comply with safety standards and respect privacy and confidentiality

Review data collection policies, storage, and inventory duties.

Skills:

Excellent communicator

Excellent organizational skills

Excellent presentation skills

Ability to multitask

Ability to lead

Ability to work independently

Highly effective interpersonal skills.

 

Personal Attributes:

Organized

Pay close attention to detail

Able to work in a fast-paced environment

Willing to travel and work off site (up to 25%)

Education:

A bachelor's degree in business management, biology, health care management, or a related field

A post bachelor’s degree certificate for clinical trial manager (including advanced training in clinical research writing, site management, and statistical analysis) is preferred

Experience:

At least 5 years’ experience as clinical study manager is required

 

Information for recruitment agencies

As a growing company, we are aware that there are a large number of agencies looking for an opportunity to work with us. However, at present, we operate a preferred supplier list. If you are interested in working with us, please contact us via email only to: recruitment@spheremedical.com

On receipt we will keep your details on file and contact you if we require assistance with a particular role.