Clinical Study Manager
Cambridge, United Kingdom
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
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.
Excellent organizational skills
Excellent presentation skills
Ability to multitask
Ability to lead
Ability to work independently
Highly effective interpersonal skills.
Pay close attention to detail
Able to work in a fast-paced environment
Willing to travel and work off site (up to 25%)
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
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: firstname.lastname@example.org
On receipt we will keep your details on file and contact you if we require assistance with a particular role.